Working to Ensure Safe Assembly of Surgical Tools

By ThinkReliability Staff

A 2-month old was undergoing a cystoscopy to incise a ureterocele in the bladder.  During the endoscopic procedure, a resectoscope was used to remove the unwanted tissue.  However, during the operation part of the resectoscope slipped off, exposing a hook-shaped internal piece of the instrument.  Fortunately the patient was not injured; however the potential for injury was very real.  How did the medical instrument come apart?

The first step in an incident investigation is to determine what the problem is and what the impacts to the organization’s goals are.  In this case, the problem is fairly straightforward – the resectoscope fell apart while inserted into a patient.  Although details are scant in this case, the problem statement is filled out as completely as possible to document what occurred.  The second part is to determine the impact to the organization’s goals.  An obvious impact is the potential harm to the patient, related to the hospital’s patient safety goal.  There was also the possibility of legal action, which would impact property goals.  Finally, there likely was the need to redo the procedure, taking additional time, thus impacting the organization’s labor goal.

The second step is to build a Cause Map by asking why an event occurred.   The Cause Map visually depicts what led to the young patient being exposed to harm.  In this case, the three goal impacts converge on the event where the hook electrode became uncovered.  It should be noted that multiple causes led to the patient being exposed to harm; if the resectoscope had been broken but had not been in use, then it would not have mattered.  It is crucial to include all reasons on the Cause Map because those reasons may be key to developing the optimal solution.

Facts that need to be captured about an investigation can be included in evidence boxes on the Cause Map.  They can provide the reader with important background information.  In this example, information about the hook electrode is included so that the reader knows what it is.

Reviewing the complete Cause Map, it turns out that the resectoscope was incorrectly assembled.  The third step in an incident investigation is to develop a set of solutions.  Remembering that all causes are necessary to produce an effect, the investigation team can brainstorm solutions to eliminate or counteract contributing causes.  In this case, three possible solutions were developed.  It is possible that the resectoscope could be designed differently so that the insulation would not be able to slip.  While this is a reasonable long term solution, it would not immediately remedy the problem.  Another solution would be to verify that the instrument is in working order before using on a patient.  This may have occurred, but it should be included until ruled out as a potential solution.  A final idea is to revise the assembly procedures for the resectoscope.  This is in fact what the FDA recommended.

The FDA recommends that the manufacturer’s assembly procedures always be carefully followed.  A process map is another helpful tool to determine where something went wrong.  The organization can build a process map depicting the ideal sequence of events, then compare that with what actually occurred.  The problem may not be in the instructions; the instructions might be perfect!  However, if someone doesn’t follow those instructions correctly, the process isn’t going to reach the desired outcome.

At this point, the investigation team might go back to the Cause Map to elaborate on the why the resectoscope was incorrectly assembled.  This might generate new solutions and changes to the ideal process map.  Through this iterative process, an optimum solution can be found.

This event was reported as part of the FDA’s MedWatch program.  The FDA encourages health professionals to voluntarily report problems on medical devices.  For more information on the MedWatch program, please visit their website.