BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 3161875 · Received June 7, 2013

    Report

    Report Number
    8010047-2013-00176
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    October 19, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    FDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY RETURNED ON TJF-Q180V WITH SERIAL NUMBER 2101850 ALONG WITH TWO TJF-160VFS WITH SERIAL NUMBERS: (B)(4) TO OLYMPUS FOR EVALUATION. THE TWO TJF-160VFS WAS RECEIVED WITH A TORN BENDING SECTION COVER. ALL RETURNED DUODENOVIDEOSCOPES WERE SENT TO AN OFFSITE LABORATORY FOR MICROBIOLOGICAL TESTING. THE TJF-Q180V WITH SERIAL NUMBER (B)(4) WAS TESTING. THE TJF-Q180V WITH SERIAL NUMBER (B)(4) WAS TESTED POSITIVE FOR KLEBSIELLA PNEUMONIA. THE TWO TJF-160VFS DID NOT GROW ANY MICROORGANISMS. FOLLOWING THE MICROBIOLOGICAL TESTING THE DUENDOVIDEOSCOPE (SUBJECT) WAS RETURNED TO OLYMPUS FOR PHYSICAL EVALUATION. THE BIOPSY PORT, BIOPSY CHANNEL, SUCTION CYLINDER AND SUCTION CHANNEL OF THE DUODENOVIDEOCCOPE WERE EXAMINED WITH A BOROSCOPE AND NO RESIDUE OR DEBRIS WAS FOUND. HOWEVER, A TEAR IN THE BENDING SECTION WAS NOTED, WHICH CAUSED THE DEVICE TO FAIL THE LEAK TEST. IN ADDITION, THE SUBJECT DEVICE HAD DEEP SCRATCHES ON THE EDGE OF THE DISTAL END COVER. THE DEVICE RECOMMENDED FOR MAJOR REPAIR. AS PART OF OUR INVESTIGATION WITH THIS REPORT, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO OBSERVE THE USER FACILITY'S REPROCESSING PRACTICES AND PROVIDED REPROCESSING TRAINING PER THE USER FACILITY'S REQUEST. DURING THE ONSITE VISIT THE ESS OBSERVED THAT THE USER FACILITY STAFF WAS NOT PRE-CLEANING, LEAK TESTING, AND PRESSURIZING THE ENDOSCOPE BEFORE SUBMERGING THE DEVICE IN THE WATER. ADDITIONALLY, THE STAFF WAS NOT USING THE AIR/WATER CLEANING ADAPTER, NOR USING THE CORRECT SUCTION CLEANING ADAPTER. PLEASE CROSS REFERENCE MFR. REPORT # 8010047-2013-00172, 00173, 00175, 00176, AND 00177.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE A CORRECTION TO THE INITIAL MDR THAT WAS SUBMITTED. BASED ON FURTHER REVIEW OF THE REPORT, IT HAS BEEN DETERMINED THAT 9 ADDITIONAL MDRS ARE NEEDED TO ACCOUNT FOR THE NUMBER OF PATIENTS ALLEGEDLY INFECTED. PLEASE CROSS REFERENCE THESE ASSOCIATED REPORT NUMBERS: 22951238-2015-00116, 2951238-2015-00117, 2951238-2015-00118, 2951238-2015-00119, 2951238-2015-00120, 2951238-2015-00121, 2951238-2015-00122, 2951238-2015-00123, AND 2951238-2015-00124.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS TO PROVIDE ADDITIONAL INFORMATION BASED UPON AN INTERNAL REVIEW OF THE COMPLAINT FILES AND FIELD SERVICE REPORTS. ON (B)(6) 2013, AN OLYMPUS SALES REPRESENTATIVE WAS INFORMED BY THE USER FACILITY THAT THEY HAD ANOTHER INFECTION CONTROL INCIDENT RELATED TO DUODENOSCOPES WITH (B)(6) AND NOT KLEBSIELLA. ON (B)(6) 2014 THE NURSE MANAGER AT THE USER FACILITY FURTHER REPORTED THAT THERE WAS A RECURRENCE OF PATIENTS TESTING (B)(6) FOR KLEBSIELLA AND (B)(6). THE USER FACILITY WAS NOT ABLE TO PROVIDE THE EXACT NUMBER OF PATIENTS THAT TESTED POSITIVE FOR THE AFOREMENTIONED MICROORGANISMS. IN ADDITION, THE USER FACILITY WAS NOT SURE IF THESE PATIENT INFECTIONS WERE RELATED TO SCOPE PROCEDURES. THE USER FACILITY REVIEWED 700 CHARTS. A SITE VISIT CONDUCTED BY AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) ON (B)(6) 2014 INDICATED THAT THE ESS OBSERVED THAT THE DOUBLE CHANNEL SCOPE WAS BEING REPROCESSED WITHOUT THE CHANNEL CONNECTION TUBE. THE ESS REPORTED THAT ONE OF THE SINK WAS CONSTANTLY FULL OF WATER, AND THE OTHER SINK WAS CONSTANTLY FULL OF WATER AND DETERGENT. THE USER FACILITY WAS MADE AWARE THAT THE SINK FLUIDS SHOULD NOT BE REUSED. THE AIR WAS NOT BEING REMOVED FROM THE SCOPE AFTER LEAK TESTING. THE ESS ADVISED THE TECHNICIAN THAT THE LEAK TESTER (MB-155) MUST BE PULLED FROM THE MAINTENANCE UNIT (MU-1) TO RELEASE THE AIR OUT OF THE SCOPE. THE ESS WAS INFORMED BY THE TECHNICIANS AT THE FACILITY THAT SEVERAL SCOPES WERE PROVIDED TO THEM WITHOUT BEING PRE-CLEANED. THE ACTING CHARGE NURSE WAS INFORMED ABOUT THIS OBSERVATION, AND THE CHARGE NURSE DIRECTED THE TECHNICIANS AND PROCEDURE ROOM PERSONNEL TO PERFORM PRE-CLEANING. THERE WERE SCOPES ON THE TABLE BEHIND THE CLEANING SINKS THAT WERE NOT IN A TRAVEL CONTAINER. THE SCOPES WERE BEING STRUCK BY TRAVEL CONTAINERS AS MORE AND MORE CONTAINERS WERE BEING PUT ON THE TABLE. THE ESS OBSERVED THAT THERE WERE FIVE SCOPES BEING PLACED IN ONE TRAVEL CONTAINER AS COMPARED TO ONE SCOPE PER TRAVEL CONTAINER. THE REPROCESSING MANUAL INSTRUCTS USERS TO DO THE FOLLOWING: "AFTER REPROCESSING, MAINTAIN APPROPRIATE TRANSPORTATION AND STORAGE PROCEDURES TO KEEP REPROCESSED ENDOSCOPES AND ACCESSORIES AWAY FROM CONTAMINATED EQUIPMENT. IF THE REPROCESSED ENDOSCOPE OR ACCESSORIES BECOME CONTAMINATED BEFORE SUBSEQUENT PATIENT PROCEDURES, THEY COULD POSE AN INFECTION CONTROL RISK TO PATIENTS AND/OR OPERATORS WHO TOUCH THEM. STORE THE ENDOSCOPE AND ACCESSORIES IN AN ENDOSCOPE STORAGE CABINET THAT ALSO PROTECTS THE EQUIPMENT FROM PHYSICAL DAMAGE." CROSS REFERENCE MFR. REPORT NUMBERS: 8010047-2013-00172, 8010047-2013-00173, 8010047-2013-00174, 8010047-2013-00175, 8010047-2013-00177, 2951238-2014-00004, 2951238-2015-00116, 2951238-2015-00117, 2951238-2015-00118, 2951238-2015-00119, 2951238-2015-00120, 2951238-2015-00121, 2951238-2015-00122, 2951238-2015-00123, 2951238-2015-00124.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE CUSTOMER HAD CULTURED FOUR OF THEIR DUODENOVIDEOSCOPES AND THEY ARE FOLLOWS: MODELS TJF-Q180V, WITH THE FOLLOWING SERIAL NUMBERS: (B)(4) AFTER HIGH-LEVEL DISINFECTION AND THE DUODENOSCOPES TESTED POSITIVE FOR THE FOLLOWING BACTERIA: KLEBSIELLA PNEUMONIAE, PSEUDOMONAS AEROGINOSA, AND ENTEROCOCCUS. HOWEVER, THE USER FACILITY REPORTED THAT NOT ALL THREE DUODENOVIDEOSCOPES GREW ALL THREE ORGANISMS, BUT RATHER IT WAS A MIX. THE USER FACILITY FURTHER REPORTED THAT ONE OF THE 160 DUODENOVIDEOSCOPES ALSO CULTURED AND GREW KLEBSIELLA PNEUMONIAE. THE USER FACILITY FURTHER REPORTED THAT THERE WERE 15 CASES OF PT INFECTION AND THEY BELIEVED THAT IT IS RELATED TO THE DUODENOVIDEOSCOPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253330 OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEM CORP TJF-160VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other