EVIS EXERA COLONOVIDEOSCOPE

Additional Manufacturer Narrative

THE DEVICE REFERENCED IN THIS REPORT WAS SENT TO A LABORATORY FOR MICROBIOLOGICAL TESTING. THE TESTING CONFIRMED THAT THE DEVICE WAS POSITIVE FOR CLOSTRIDIUM PERFRINGENS AND ENTEROCOCCUS FAECALIS. IN ADDITION, THE DEVICE WAS FORWARDED TO OLYMPUS FOR EVALUATION FOLLOWING THE LABORATORY MICROBIOLOGICAL TESTING. THE EVALUATION FOUND SMALL AMOUNTS OF WHITE DEBRIS INSIDE THE CHANNEL MOUNT UNIT, SUCTION CYLINDER UNIT, AND THE INLET AND PROXIMAL ENDS OF THE AUXILIARY WATER CHANNEL. THE DEVICE WAS REPAIRED AND RETURNED TO THE FACILITY. AS PART OF OUR INVESTIGATION, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE FACILITY TO REVIEW AND PROVIDE IN-SERVICE TRAINING ON REPROCESSING PROCEDURES. NO SIGNIFICANT REPROCESSING DEFICIENCIES WERE NOTED DURING THE ESS VISIT. HOWEVER, AN OLYMPUS MICROBIOLOGISTS AND SALES REPRESENTATIVE PERFORMED A FOLLOW-UP VISIT TO THE USER FACILITY TO FURTHER INVESTIGATE THIS MATTER. DURING INTERVIEWS WITH THE FACILITY PERSONNEL, ONE OF THE REPROCESSING TECHNICIANS WAS FOUND TO BE UNAWARE THAT THE SUBJECT DEVICE WAS DESIGNED WITH AN AUXILIARY WATER CHANNEL. ADDITIONALLY, THE FACILITY WAS FOUND NOT FLUSHING THE CHANNELS OF THE DEVICE WITH ALCOHOL FOLLOWING REPROCESSING, AND HAD BEEN STORING THE DEVICE IN A NON-VENTILATED CABINET. THE OLYMPUS REPRESENTATIVES HAVE PROVIDED IN-SERVICE TRAINING ON THE APPROPRIATE REPROCESSING PROCEDURES. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, FAILURE TO FOLLOW REPROCESSING STEPS AND NOT PROPERLY STORING THE DEVICE COULD BE A CONTRIBUTING FACTOR.

Description of Event or Problem

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 NINE PATIENTS INVOLVED IN THIS EVENT. THE USER FACILITY REPORTED A CLUSTER OF CLOSTRIDIUM DIFFICILE AMONG NINE PATIENTS THAT UNDERGONE ENDOSCOPY PROCEDURES. EIGHT OF THE PATIENTS UNDERWENT COLONOSCOPIES, AND ONE PATIENT UNDERWENT A GASTROSCOPY, BETWEEN (B)(6) 2009. ONE OF THE COLONOSCOPY PATIENTS WAS REPORTED TO HAVE BEEN HOSPITALIZED FOR AN UNSPECIFIED AMOUNT OF TIME. IT WAS REPORTED THAT TWO OF THE PATIENTS HAD DIARRHEA PRIOR TO THE PROCEDURES. THE NINE AFFECTED PATIENTS HAVE BEEN NOTIFIED AND ARE REPORTEDLY DOING FINE. ADDITIONALLY, THE DOCTOR STATED THAT OTHER COLONOSCOPIES WERE PERFORMED DURING THE SPECIFIED TIME PERIOD OF THE CLUSTER AND NO SIMILAR SYMPTOMS HAVE BEEN REPORTED WITH THOSE PATIENTS. OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA PHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT, HOWEVER ONLY LIMITED INFORMATION WAS RECEIVED. PLEASE CROSS REFERENCE MFR. REPORT NUMBERS: 8010047-2010-00007, 8010047-2010-00008, 8010047-2010-00009, 2951238-2016-00174, 2951238-2016-00175, 2951238-2016-00177, 2951238-2016-00178 AND 2951238-2016-00179 TO ACCOUNT FOR THE NINE PATIENTS AS REFERENCED IN THE ORIGINAL REPORT. THE FOLLOWING REPORTS WILL BE SUPPLEMENTED TO CROSS REFERENCE THE NINE ASSOCIATED INFECTION COMPLAINTS: (B)(4).