UNKNOWN

Additional Manufacturer Narrative

THE DEVICES HAVE NOT BEEN RETURNED TO OMSC FOR EVALUATION. SINCE THE SERIAL NUMBERS OF THE DEVICES WERE NOT INFORMED, OMSC COULD NOT CONFIRM THE MANUFACTURING HISTORY. OLYMPUS RECEIVED THE REQUEST FROM THE USER FACILITY AND INSTRUCTED THEM REPROCESSING METHOD ON NOVEMBER 27TH, 2018. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

Description of Event or Problem

OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE USER FACILITY EXPERIENCED SEVEN PATIENTS INFECTION WITH MULTIDRUG-RESISTANT PSEUDOMONAS AERUGINOSA (MDRP) SINCE AUGUST 2018, AND SIX OF THE SEVEN PATIENTS UNDERGONE ENDOSCOPY. SINCE SOME OF THE SIX PATIENTS EXPERIENCED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES, THE USER FACILITY IS SUSPECTING THE CAUSAL RELATIONSHIP BETWEEN THE INFECTION AND THE ENDOSCOPY. THE MODEL NAMES OF THE DEVICES WHICH USED FOR EACH PATIENT ARE UNKNOWN. AS A RESULT OF THE MICROBIOLOGICAL TESTING FOR THE SUBJECT DEVICE BY THE USER FACILITY, NO MICROBE WAS DETECTED FROM THEM. THE USER FACILITY IS PLANNING ADENOSINE TRI-PHOSPHATE (ATP) TESTING FOR THE DEVICES. THE DEVICE HAD BEEN REPROCESSED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL OER-3 (NOT AVAILABLE IN THE USA). IT WAS REPORTED THAT THREE OF THE SIX PATIENTS HAVE ALREADY BEEN DISCHARGED, AND THERE IS NO INFORMATION REGARDING THE OTHER THREE PATIENTS. OLYMPUS IS SUBMITTING MDR ACCORDING TO THE NUMBER OF THE PATIENTS WHO WERE INFECTED POTENTIALLY ASSOCIATED WITH THE ENDOSCOPE. THIS IS 6TH OF 6 REPORTS.

Additional Manufacturer Narrative

IT WAS FURTHER CLARIFIED THAT THE NUMBER OF PATIENTS INFECTED WITH MULTIDRUG-RESISTANT PSEUDOMONAS AERUGINOSA (MDRP) WAS NOT SEVEN BUT EIGHT. AT THIS TIME, IT IS UNCERTAIN WHETHER THE ADDITIONAL PATIENT EXPERIENCED ENDOSCOPY OR NOT. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE OUTCOME OF THE PATIENT IN THE INITIAL REPORT BASED ON ADDITIONAL INFORMATION. OLYMPUS WAS INFORMED THAT THE DISCHARGE OF THE THREE PATIENT FROM THE USER FACILITY WERE UNCERTAIN INFORMATION. THE OUTCOMES OF ALL SIX PATIENTS ARE NOT PROVIDED FROM THE USER FACILITY AT PRESENT. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.