BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 45CM PEEK MULTI-FUNCTION HANDLE

    MDR report key: 3914608 · Received July 3, 2014

    Report

    Report Number
    0002936485-2014-00449
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 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: THE RATCHET FUNCTION ON THE HANDLE WAS UNDAMAGED. DENTS AND SCRATCHES WERE NOTICED THROUGHOUT INSULATION. CRACKS WERE ALSO 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 CAUSES FOR THE DENTS AND SCRATCHES TO THE INSULATION COULD BE DUE TO: 1) USER MISHANDLING OR 2) IMPROPER STERILIZATION METHODS. THE PROBABLE ROOT CAUSES FOR THE CRACKS ON THE INSULATION COULD BE DUE TO: 1) USER MISHANDLING, 2) IMPROPER STERILIZATION METHODS, OR 3) NORMAL WEAR AND TEAR. 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
    391738 5MM, 45CM PEEK MULTI-FUNCTION HANDLE ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 0441296C

    Patients

    Seq Age Sex Outcome Treatment
    1