BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 11810530 · Received May 12, 2021

    Report

    Report Number
    8010047-2021-06181
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Report Date
    July 9, 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

    THE DEVICE WAS RETURNED TO OLYMPUS REPAIR CENTER, BUT NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). THEREFORE, OMSC COULD NOT CONFIRM THE DEVICE. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OMSC CONFIRMED SIMILAR COMPLAINTS AND FOUND SURMISED THAT THIS PHENOMENON ATTRIBUTED TO REPEATED PHYSICAL STRESS OR CHEMICAL STRESS ON THE DISTAL END. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE INSPECTION BY OTH ASLO CONFIRMED FOLLOWINGS; THE PLAY OF THE ANGLE KNOB WAS OUT OF THE STANDARD DUE TO THE WEAR OF THE ANGLE WIRE. THERE WAS A SCRATCH ON THE CONNECTION TUBE. THE ADHESIVE ON THE BENDING SECTION RUBBER HAD PEELED OFF. THE EXACT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN IDENTIFIED BY LEGAL MANUFACTURER OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THIS DEVICE. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS ((B)(4)) CO., LTD. (OTH) AND FOUND THAT THERE WAS A GAP IN THE ADHESIVE AREA BETWEEN THE PLASTIC COVER AND THE DISTAL END. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710350 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V 04953170367311

    Patients

    Seq Age Sex Outcome Treatment
    1