Olympus followed up with the user facility via telephone and in writing to gather additional information, however, only limited information was provided.The device returned to olympus for service with a report of heavy corrosion on the bending section and distal end.The evaluation confirmed the user report of heavy corrosion.The insertion tube had deep cuts and blisters, and the unit failed insulation testing.The instrument channel was also kinked.The device was serviced.As part of our follow-up into this report, an endoscopy support specialist (ess) visited the facility to assess the reprocessing practices and to provide in-service on how to properly reprocess endoscopes.Based upon the information provided by the ess, the facility was not to be reprocessing the device in accordance with the device instruction manual.The facility was not using enzymatic detergent during manual cleaning and was not performing leak testing.The ess provided training on proper reprocessing steps.The cause of the event could not be determined; however, not following reprocessing steps could likely contribute to the reported event.
|
Oca undertook a retrospective review of its mdr files for the period of january 2005 to april 2015.Based upon this review, we are submitting this mdr to separately account for each of the seven patients involved in this event.The user facility reported seven cases of pseudomonas infections after having undergone a cystoscopy procedure.All of the patients were said to have required antibiotics for treatment, and three of the patients were hospitalized.The status of the patients is not currently known.Please cross reference mfr.Report numbers: 2951238-2016-00168, 2951238-2016-00169, 2951238-2016-00170, 2951238-2016-00172 and 2951238-2016-00173 to account for the six patients as referenced in the original report.The following report will be supplemented to cross reference the six associated infection complaints: 9610773-2010-00027.
|