BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 45CM MONOPOLAR HANDLE

    MDR report key: 3924529 · Received July 10, 2014

    Report

    Report Number
    0002936485-2014-00459
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 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

    THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. VISUAL INSPECTION: DENTS AND SCRATCHES WERE NOTICED ON THE INSULATION. FUNCTIONAL INSPECTION: THE INSULATION WAS TESTED FOR CRACKS/DAMAGES USING AN INSULSCAN. THE INSULATION FAILED THE INSULSCAN TEST. THE PROBABLE ROOT CAUSE FOR THE DENTS AND SCRATCHES TO THE INSULATION IS LIKELY DUE TO IMPROPER STERILIZATION METHODS. THE PROBABLE ROOT CAUSES FOR THE INSULATION FAILING THE INSULSCAN TEST COULD BE DUE TO EITHER IMPROPER STERILIZATION METHODS OR NORMAL WEAR AND TEAR. IN SUM, THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

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

    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
    404313 5MM, 45CM MONOPOLAR HANDLE ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 0747491D

    Patients

    Seq Age Sex Outcome Treatment
    1