Patient Safety - Health Committee Contents

Memorandum by Mrs Clare Bowen (PS 79)



  Bethany Bowen had a hereditary blood condition (spherocytosis) that resulted in anaemia and significant swelling of the spleen. She was healthy and normal in every other way, and was able to attend school, interact with other children and engage in play. Visible symptoms were a slightly yellow skin, and the appearance of an enlarged stomach (due to the swelling of the spleen). Her condition required monitoring, but she was coping well with it at the time of the operation even with the complication of three small gallstones. The operation was necessary at some point in her childhood as existing alternatives are inadequate.

  The operation is normally straightforward and comparatively risk free.

  The procedure consented to by the parents:

    Laparoscopic surgery would be employed to mobilise the spleen. The spleen would then be dropped into the pelvic area, where it would be removed via a bikini-line incision. Following splenic removal, the gall bladder would be opened and gall stones removed.

  The procedure carried out:

    Laparoscopic surgery was employed to mobilise the spleen. A morcellator was employed to break up the spleen inside an endoscopic bag, inside the body cavity. The morcellator blade was applied to the spleen via a small opening in the abdominal wall. Collapse occurred during this process and the rest of the operation had to be abandoned. Beth died in theatre never recovering from initial collapse.


  The following points are based on information gathered from letters, reports, and audio recordings of meetings held at the John Radcliffe Hospital and the inquest at Oxford Coroners Court.

    — The proposed procedure for spleen removal was changed after the consent forms were signed by the parents.

    — The parents were not informed of this change, or of any additional risks this entailed.

    — No reason was given as to why the proposed procedure was changed at the last minute.

    — The new procedure involved the use of a morcellator, which carried considerably more risk to the patient. The risks associated with the morcellator significantly outweighed the benefits.

    — The new procedure was a training exercise.

    — The doctor operating the morcellator was a trainee, and had never operated the tool before or heard of the procedure before that morning.

    — The surgeon directly supervising him had never seen or operated the tool before.

    — A third surgeon, believed to have some experience (but not in the UK and a number of years ago), was present in the room but not watching the tool in operation.

    — This is considered by both the Trust and the surgeons as a perfectly acceptable definition of conducting an operation using trained staff.

    — Evidence was destroyed: including the bag containing the spleen; the swabs; all the disposable parts of the morcellator including the blade; the bag applicator, and all the blood collected.

    — Poor record keeping: an independent anesthetist examined some of the medical notes and found them to be completely inadequate, in terms of insufficient detail, and numerous omissions.

    — Post mortem examination revealed Bethany's Aorta to have two complete cuts, approximately 1cm apart. (It should be noted that the diameter of the morcellator blade is approximately 1cm.)

    — With regard to the cuts, the testimony by the surgeons present in the operating theatre shifted from:
(a)July 2006 (following Bethany's death): blood vessel accidentally cut with morcellator resulting in major blood loss and death. To,
(b)January 2007 (Recorded meeting): Aorta cut in two places, probably with the morcellator, but the resulting blood loss was not significant. Cause of death unclear. To,
(c)November 2007 (Inquest): Aorta certainly not damaged by the morcellator, and the two cuts found have no explanation. Blood loss from the cuts insignificant, and cause of death unclear.

    — Cuts were found to her large intestine and stomach, in addition to those found in the aorta. No explanation was given as to the cause of these cuts.

    — The doctors have dismissed all suggestion they caused her death either through their actions or inaction, but have not presented any alternative explanation.

    — The Trust failed to satisfactorily investigate the events surrounding Bethany's death, and pursued a strategy of misinformation and obfuscation, including circulation of documents containing gross inaccuracies relating to the family. The only actions that could be seen as proactive on their behalf were failed attempts to find a pre-existing medical condition in the family.

    — The family were forced to appoint a solicitor in an effort to overcome difficulties in dealing with the Trust and to fight for a full inquest.

    — Sixteen months after Bethany's death the Trust admitted liability for not gaining adequate consent, and for not having proper training procedures. However, a number of surgeons, when giving evidence at the coroners inquest, refuted the suggestion relating to inadequate consent, and stated that the training was sufficient.

    — Instructions laid down by the manufacturer of the endo bag, which specifically state that a morcellator should not be used with this bag on the grounds of safety, were ignored by the surgeons operating on Beth. This was not acknowledged as an error of judgment. On the contrary, the need to comply with the manufacturers instructions was disputed in the coroner's court.

    — Training in the UK is offered and indeed recommended by the supplier of the morcellator (both at an external training centre, and on site at the hospital) but was not undertaken. The surgeons believe the morcellator is too simple a piece of equipment to require such training.

    — Consultant surgeons are not required to log or record any of their training or experience. They are able to say to a hospital "I am trained on this piece of equipment" and that is usually considered sufficient. They do not have to prove it or show any records before carrying out the procedure.

    — First indication from the anaesthetist of Bethany's collapse occurred at 1615. The circulating nurse was told to leave at 1630. This instruction was unprecedented in his experience. A senior staff nurse took over as circulating nurse, and observed the doctors having a discussion about what to do next. They were not attempting CPR at that point. Attempts were made to release the other circulating nurse at 1645, but she resisted. She was relieved from duty at 1710.

    — It has been stated that 1630 was the scheduled end of the nurses' shift. This does not satisfactorily explain why a senior member of staff attempted to enforce a shift change during a medical emergency. Indeed, it is astonishing.

    — A report into what happened to Bethany and what procedural changes would be made was promised by the JR Trust following her death. At the time of writing, two years, three and a half months have passed since Bethany's death and the family have received plenty of excuses, but no report.


  1.  Bethany's death is a mystery. It occurred due to a symptomless pre-existing medical condition that was not diagnosed, not detected at post-mortem, and manifested itself simultaneously with cuts appearing in the aorta, leading to a stopping of the heart. The actions of the surgeons did not cause her death.

  2.  Bethany's death has a scientific explanation. This would almost certainly have been established had

    (i) all the above-mentioned evidence been safeguarded,

    (ii) cameras been fitted to the walls of the operating theatre and their data verifiably protected.

    (iii) Data gathered by heart function and other vital organ monitoring equipment been recorded automatically, in real time, and protected with tamper seals.

    (iv) a national and independently appointed investigation team been brought in whenever an incident such as this takes place. This team should consist of people with an investigative background (eg former police officers), as well as medically trained members.

  The verdict from the inquest stated that Bethany's aorta was damaged by an unspecified surgical instrument. No attempt was made to hold any surgeon responsible for their actions, and no recommendations were made by the coroner.


  The time has to come to acknowledge that medical staff may not always be forthcoming with all the facts following the death of a patient that they were directly involved with. To do so could damage or even terminate their career, and implicate colleagues with whom they work closely.

  It should also be recognised that it is not in the interests of the NHS Trust to publish information that reveals human error and serious shortcomings in procedure. They have a reputation to protect.

  This may seem obvious, but the experience of the witness both in the 16 months prior to the inquest and during the inquest itself, is that the testimony of the doctors is ultimately decisive in determining the facts.

  It is the key recommendation of this report that the only way to prevent a repeat of this accident, reduce the level of similar incidents, and safeguard against cover-up, is to introduce all the points listed in 2. i to iv above and to set up a regulatory body (either within or outside the NHS) that monitors and records all doctors training with new procedures, ensuring they are fully assessed and documented rather than the "lets have a go" approach used in Beth's case.

  Also, it is common knowledge that clinicians close ranks, feeling they are under siege, when things go wrong. It would have taken a brave doctor or nurse to speak out after Bethany's death.

  The railway industry has a reporting system known as CIRAS. This stands for "Confidential Incident Reporting and Analysis System".

  "CIRAS is an alternative way for rail industry staff to report safety concerns that they feel unable to report through company safety channels. It is a completely independent and confidential way to report safety concerns without fear of recrimination." []

  CIRAS has been in place for many years—the work has already been done—the government need only liaise and adopt this system for the NHS. We strongly recommend they do this.


  We were informed of her death by the surgical team, whilst on the ward in front of other patients and visitors, and were not taken somewhere more private. Following disclosure of this devastating news, we were left to leave the ward and walk out of the hospital via the main entrance unaided and unaccompanied by any hospital staff. We were not asked as to our means of getting home, and we were not in a fit state to drive. By chance, other family members were available to drive us, but the hospital did not know this.

  The hospital contacted us the following day, and arranged for a bereavement services appointment. However, the hospital later cancelled this visit, and offered no explanation.

  No information was given to us unless we asked the right question, and even after we asked if all of the information had been given to us they produced new photos and slides at the inquest.

  We spent a very long time talking to the hospital about Beth and what had happened, but all new information we received was because of questions we asked, they never volunteered information and they were always very closed and defensive towards us.

  They never said sorry other than in a letter from their solicitors after the inquest when they admitted liability. [N.B. Liability admitted by the Trust; the surgeons remained in denial.]

  None of them saw Beth as a little girl only a patient to practice on, another patient to wheel through the theatre.

  If any of the operating team had stopped to question each other on what they were doing, or had been made, by procedure, to discuss options then I believe Beth would still be alive today, why did no one say,

    — Is it not better to remove a broken bag than leave a child under anesthetic for an extra 45 minutes?

    — Is it not better to get some retraining as you have not used this equipment for 3 to 4 years?

    — Is it not better for the trained doctor to be hands on rather than outside the operational field watching a screen where the manufacturers [of the endo bag] believe you would not be able to see anything if it did go wrong?

    — Is it not right to inform the parents we have altered the operation plan?

    — This piece of equipment is not made specifically for paediatrics and had never been used in UK for splenectomy before. Do we not need more than a conversation on the morning of the operation before we go ahead and use it?

  Why is it in the field of surgery that doctors training and experience allows them the right to make decisions without question and without fear of being held to account?

  When I signed the consent form I believed a doctor who had relevant training was operating on Beth. This was not the case. Would you get onto an aeroplane with a pilot who did not know how to fly, with a copilot who had had it explained but never seen it done and a cabin crew who said they had done it three to four years ago, this is comparatively what situation they put Beth into.


  The Gynecare morcellator has a nose (or barrel) of approximately 20cm in length with a rotating blade protruding at the tip, in order to reach and cut tough material in parts of the body difficult to access by any other means. It has been specifically designed for use in gynaecology, where it is often used in hysterectomies.

  It had not been used to break up a spleen inside an endo bag, laparoscopically, in paediatric surgery before, either at the JR, or anywhere else in the UK. The following are some of the risks associated with this new type of surgery:

    1. The blade is capable of 1000rpm (although the surgeons who operated on Bethany state they used it on the lowest speed setting).

    2. Located at the tip, the blade cannot be seen as it cuts into the spleen, which is inside an endoscopic bag within the abdomen.

    3. The nose (or barrel) is too long for this type of operation. The surgeons stated at the inquest that they applied the tip no more than 2 or 3 centimetres into the abdomen. However, it is difficult to know precisely how far the device had been pushed in, without any gradations or marking to give an indication. An extra one or two centimeters could result in cutting through the bag and causing injury, and some point of reference is clearly essential—especially when the operator has no experience. To reiterate: they could not see the blade, and were relying on a best guess as to how deep it had penetrated.

    4. A laparoscopic (or keyhole) camera was used, which gave a limited view of the bag inside the abdomen. During the inquest the court heard that the field of view was very restricted, showing only one side of the bag. Had the blade penetrated the other side, this would not be visible on the monitor screen.

    5. The inquest heard of an incident which occurred in the USA in 2006, when a morcellator was used on a woman patient, to cut up the spleen inside an endo bag. The morcellator went through the bag, cut her aorta, and the patient died.

    6. When used with inadequate training, (for whatever procedure) it is potentially dangerous. The representative from [Johnson and Johnson] stated, "I would not advise anyone to use the morcellator without first attending our training course, where the user practices on a cows tongue."

Why would a Morcellator be used in this type of operation?

  The lead surgeon cited the following advantages:

    "You can remove the spleen piecemeal, not the total spleen, but partly remove it piecemeal to make it more softer [sic] and then remove it with the forceps."

  In addition, the morcellator will, in theory, speed up the process of spleen removal, which was of some relevance in Bethany's operation because the surgeons had intended to proceed to remove gall stones, after the splenectomy. However, had time been a critical factor in this operation, it should be noted that the surgeons lost 45 minutes in the early stages in attempting to place the spleen into a damaged bag, before abandoning it and using a replacement bag. They cited the cost of wasting a disposable bag as the reason for their 45 minutes of perseverance. Safety to the patient, and time lost, was not a factor that seemed important during that part of the procedure.

  It should also be noted that there are safer, proven, alternative techniques for breaking up the spleen inside a bag, which make use of blunt instruments.


  As a new technique it is attractive to surgeons. As surgeons they are "hands on", and there is clearly a degree of excitement about pioneering a new technique. Individual surgeons gain recognition within their profession and in the media for being the first to introduce new methods and embrace new technologies, that go on to become adopted by the profession at large.


  The difficulty is that there are no systems in place to hold them back. They are able to make spur-of-the-moment decisions that radically alter the risks to the patient. They are not compelled to comply with manufacturer's safety instructions. A representative of the manufacturer of the endo bag, whilst giving evidence stated: "We've, in our experiments and in our research, discovered the bag is fantastic for keeping soft tissue and protecting wounds, wound edges, it's not intended for use in conjunction with very sharp devices…"

    "My experience is we've always said do not use the morcellator and I know that we have had experience either at the research stage, or early on in the use of the product which would suggest that the morcellator is not a good thing to do, in the bag, as you saw there it is very difficult to see what is going on in the structure when you can only see one face of it laparoscopically. The comment was 'You can't see either behind or below'".

  The instructions for use that accompany the retrieval bag specifically state that a morcellator should not be used in conjunction with it: "We stop people from doing it", he said.

  The surgeons do not have to attend training courses if they consider they have sufficient experience in the theatre. The point is—they decide. When things do go wrong, they are not held to account. This is evident from the outcome of the inquest, which stated that Bethany's aorta was damaged by an unspecified surgical instrument. No attempt was made to hold any surgeon responsible for their actions, and no recommendations were made by the coroner.


  Blood loss was recorded as not significant, but no attempt made to quantify, where quantification was possible. Records were omitted; an independent anaesthetist at a meeting stated, "There are boxes to be filled in [she proceeds to list various categories] it's just completely blank".

  The batch number and lot number of morcellator components was not logged. During a meeting with the Trust, Bethany's father, Richard, noted, "Potentially you've got a box full of faulty parts in your hospital ready to use on somebody else." This was in the context of a suggestion by the Trust that an electrical fault in the morcellator may have been the cause.

  Her weight was incorrect on the notes, and this was not queried by the anaesthetist, who said that she had assumed figures had been transposed.

  Given the magnitude of error that occurred on the day Bethany died, it is easy to lose sight of other, lesser systemic and procedural failings which, had the morcellator not been used, could have lead to other types of adverse event.


  A great deal of the testimony of the doctors was in the third person, using phrases that repeatedly referred to how a given procedure would be carried out, should be carried out, or had to be carried out, but very rarely (if at all) said what they actually did on the day Bethany died.

  Bethany's father Richard, who tragically died from heart disease brought on by the stress of losing his daughter and the painful circumstances that followed, had this to say,

    "Until the NHS is called to account for taking these risks they will simply go on killing our children… We have little faith that lessons will be learned until there is an independent body that monitors surgical training in the NHS. The risks that were taken by the Trust during the operation on Bethany were simply incredible and the attitude of the Trust was truly appalling."

November 2008

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