USER FACILITY PERSONNEL REPORTED THAT SEVERAL PATIENTS HAD REPORTEDLY COMPLAINED OF AN ALLERGIC REACTION FOLLOWING SIGMOIDOSCOPY OVER A PERIOD OF SEVERAL MONTHS. OLYMPUS WAS INFORMED THAT SIGMOIDOSCOPES AT THE USER FACILITY WERE NOT BEING REPROCESSED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, AND THE USER FACILITY WAS SIGNIFICANTLY DEVIATING FROM THE RECOMMENDED CLEANING INSTRUCTIONS INCLUDING NOT PERFORMING PRE-CLEANING, LEAK TESTING, NOR COMPLETELY SUBMERGING THE ENDOSCOPE INTO REPROCESSING CHEMICALS. THE USER FACILITY WAS ALSO REPORTEDLY INSUFFICIENTLY BRUSHING AND FLUSHING THE SIGMOIDOSCOPES CHANNELS, AND WAS EXPOSING THE DEVICES TO REPROCESSING CHEMICALS FOR VARYING LENGTHS OF TIME.
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Patient 1
OLYMPUS CONTACTED THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADD'L INFO REGARDING THIS REPORT, BUT ONLY LIMITED INFO WAS PROVIDED. OLYMPUS WAS INFORMED THAT THE SUBJECT DEVICE OF THIS REPORT WAS NOT USED IN ANY OF THE EXAMINATIONS WHERE PATIENTS WERE SAID TO HAVE DEVELOPED ALLERGIC REACTIONS FOLLOWING SIGMOIDOSCOPY. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVAL. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO OBTAIN MORE INFO, AND TO ASSESS THE REPROCESSING PRACTICES AT THE USER FACILITY. THE ESS REPORTED THAT CONFLICTING INFO WAS PROVIDED TO HIM BY DIFFERENT STAFF MEMBERS AT THE USER FACILITY. HOWEVER, THE ESS DETERMINED THAT BASED ON THE INFO PROVIDED, THAT USER FACILITY PERSONNEL WERE NOT REPROCESSING THEIR SIGMOIDOSCOPES IN ACCORDANCE WITH THE RECOMMENDED REPROCESSING PROTOCOL. THE ESS PROVIDED INSERVICE TRAINING REGARDING APPROPRIATE REPROCESSING OF ENDOSCOPES AND PROVIDED EDUCATIONAL MATERIALS. THE USER FACILITY IS REPORTEDLY PURCHASING ADD'L EQUIPMENT AND REPROCESSING SUPPLIES INCLUDING AN AUTOMATED ENDOSCOPE REPROCESSOR (AER). THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION. CROSS REFERENCE MFR REPORT NUMBER: 8010047-2010-00161 FOR A RELATED REPORT.