BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM MONOPOLAR HANDLE 33CM

    MDR report key: 3924503 · Received July 10, 2014

    Report

    Report Number
    0002936485-2014-00464
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 SHOWS DENTS ON THE SHAFT'S INSULATION. FUNCTIONAL INSPECTION : THE 5MM MONOPOLAR HANDLE 33CM WAS TESTED WITH AND INSULSCAN AND PASSED. PROBABLE ROOT CAUSES COULD BE (1) USER MISUSE (2) USER EXCESSIVE FORCE (3) IMPROPER CLEANING AND STERILIZATION (4) NORMAL WEAR IN SUM, THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION HAS BEEN COMPROMISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION HAS BEEN COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404865 5MM MONOPOLAR HANDLE 33CM ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 06172014

    Patients

    Seq Age Sex Outcome Treatment
    1