BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM MONOPOLAR HANDLE 33CM

    MDR report key: 3831306 · Received May 24, 2014

    Report

    Report Number
    0002936485-2014-00364
    Event Type
    Malfunction
    Date Received
    May 24, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. VISUAL INSPECTION: THE VISUAL INSPECTION OF THE MONOPOLAR HANDLE CONFIRMS INSULATION DAMAGE THROUGHOUT THE DISTAL END OF THE SHAFT. FUNCTIONAL INSPECTION: THE MONOPOLAR HANDLE PASSED THE INSULSCAN TEST. PROBABLE ROOT CAUSE/S FOR THE INSULATION DAMAGE COULD BE INCORRECT STERILIZATION METHODS AND OR NORMAL WEAR AND TEAR. IN SUM, THE UNIT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT PASS A CHECK TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT PASS A CHECK TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309634 5MM MONOPOLAR HANDLE 33CM ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 1040253

    Patients

    Seq Age Sex Outcome Treatment
    1