BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 11356960 · Received February 22, 2021

    Report

    Report Number
    8010047-2021-02856
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 29, 2021
    Report Date
    March 22, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170367311
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO REPORT THE ADDITIONAL INFORMATION. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE DEVICE WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE INSTRUCTION MANUAL CALLS ATTENTION TO THE IMPACT ON THE DISTAL END AS FOLLOWS; "DO NOT STRIKE, HIT, OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, OR ENDOSCOPE CONNECTOR. ALSO DO NOT BEND, PULL, OR TWIST THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD OR ENDOSCOPE CONNECTOR WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, BURNS, BLEEDING, AND/OR PERFORATIONS. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT." OMSC ASSUMED THAT THE WATERTIGHT GLUE PART BETWEEN DISTAL END AND LIGHT GUIDE LENS HAD BEEN PEELED OFF SLIGHTLY, AND DIRT HAD INVADED INSIDE THE LENS THROUGH THE GAP. BASED ON THE RESULTS OF INVESTIGATIONS OF SAME EVENTS IN THE PAST, THE FOLLOWING HANDLING MAY BE THE CAUSE. PHYSICAL STRESS CAUSED BY HITTING THE DISTAL END AGAINST AN OBJECT. CHEMICAL STRESS CAUSED BY CHEMICAL SOLUTION USED IN REPROCESSING. DETERIORATION CAUSED BY STORAGE ENVIRONMENT. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE INSPECTION OF THE DEVICE BY OLYMPUS ((B)(4)) CO., LTD. ALSO FOUND FOLLOWINGS; -ADHESIVE ON BENDING SECTION RUBBER WAS DETACHED. -CONNECTING TUBE HAD WRINKLE AND SCRATCH. 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 · 1

    THE DEVICE WAS SENT TO OLYMPUS FOR ANNUAL REPAIR. OLYMPUS INSPECTED THE DEVICE AT THE REPAIR CENTER OF OLYMPUS ((B)(4)) CO., LTD. AND FOUND THAT DIRT INSIDE THE OBJECTIVE LENS DURING THE INSPECTION FOR REPAIR. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254573 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V 04953170367311

    Patients

    Seq Age Sex Outcome Treatment
    1