BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 6700083 · Received July 11, 2017

    Report

    Report Number
    8010047-2017-00864
    Event Type
    Injury
    Date Received
    July 11, 2017
    Date of Event
    June 12, 2017
    Report Date
    February 22, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    PK954451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICES HAVE NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION SINCE THE RESULT OF ADDITIONAL MICROBIOLOGICAL TESTING BY THE FACILITY FOR THE SUBJECT DEVICES WERE NEGATIVE. OMSC REVIEWED THE MANUFACTURE HISTORY OF THE SUBJECT DEVICES AND CONFIRMED NO IRREGULARITY. OLYMPUS REPRESENTATIVE INSPECTED THE ETD-3 AND ETD-4 AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE COULD NOT BE DETERMINED AT PRESENT BUT INAPPROPRIATE STORAGE AND REPROCESSING PRACTICE AT THE USER FACILITY CANNOT BE RULED OUT AS THE CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT TWO PATIENTS WITH INFECTION BY ENTEROBACTER CLOACAE COMPLEX HAVE BEEN DETECTED AND DUODENOSCOPES WERE SUSPECTED TO BE THE CAUSE OF THE INFECTION SINCE BOTH PATIENTS UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE FACILITY ALSO REPORTED THAT IT POSSESSED THREE TJF-145 (SERIAL (B)(4)) BUT COULD NOT IDENTIFY WHICH TJF-145 WAS USED FOR THESE TWO PATIENTS. THE FACILITY REPORTEDLY HAD BEEN BRUSHING THE TJF-145 USING OLYMPUS BRUSHES (MODEL MH-507, BW-20T AND MAJ-1534) AND REPROCESSING THEM USING OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD-3 AND ETD-4 (NOT AVAILABLE IN THE USA). THE FACILITY REPORTEDLY INFORMED THE OLYMPUS REPRESENTATIVE THAT IT HAD PREVIOUSLY BEEN USING THE MH-507 BRUSH FOR BRUSHING OF DISTAL END OF THE TJF-145, BUT AFTER THE QUALITY INFORMATION (FILED SAFETY CORRECTIVE ACTION IN 2017) FROM OLYMPUS, THE FACILITY HAS USED THE MODEL MAJ-1534 BRUSH. OLYMPUS FOLLOWED UP WITH THE FACILITY AND WAS INFORMED OF THE FOLLOWING ADDITIONAL INFORMATION. ONE PATIENT UNDERWENT THE ERCP ON (B)(6) 2017 AND THE OTHER PATIENT UNDERWENT THE ERCP ON (B)(6) 2017. DURING MANUAL CLEANING, THE FACILITY DID NOT FLUSH ALL OF THE CHANNELS OF THE SUBJECT DEVICES WITH DETERGENT SOLUTION AND DID NOT BRUSH THE AIR/WATER VALVE AND SUCTION VALVE OF THE SUBJECT DEVICES. DURING STORAGE, THE FACILITY DID NOT HANG THE SUBJECT DEVICES VERTICALLY ACCORDING TO OLYMPUS INSTRUCTION MANUAL AND THE FACILITY LAID THE SUBJECT DEVICES ON RAGS. IN ADDITION, THE FACILITY DID NOT DETACH THE ENDOSCOPE ACCESSORIES SUCH AS SUCTION VALVE AND WATER RESISTANT CAP. THE FACILITY INSPECTED THE SUBJECT DEVICES AND CONFIRMED NO DEBRIS AND NO ABNORMALITY IN THE APPEARANCE. IN THE MICROBIOLOGICAL TESTING FOR THE SUBJECT DEVICES BY THE FACILITY AFTER THIS EVENT, THE TESTING INDICATED NO MICROORGANISM GROWTH FOR THE SUBJECT DEVICES. THE PATIENTS WERE GETTING WELL AND WERE DISCHARGED FROM THE USER FACILITY. THIS IS ONE OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482142 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-145

    Patients

    Seq Age Sex Outcome Treatment
    1 Other