BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM PEEK MULTIFUNCTION HANDLE

    MDR report key: 3974188 · Received August 1, 2014

    Report

    Report Number
    0002936485-2014-00563
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 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 FOR INSULATION FAILURE BUT NOT THE HANDLE. DENTS AND SCRATCHES WERE SEEN ON THE INSULATION. THE INSULATION WAS TESTED FOR CRACKED/DAMAGES. THE INSULATION PASSED THE INSUL SCAN TEST. THE PROBABLE ROOT CAUSES ARE USER MISUSE, IMPROPER STERILIZATION METHODS, OR NORMAL WEAR. IN SUM, THE UNIT 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
    449940 5MM PEEK MULTIFUNCTION HANDLE ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 07092014

    Patients

    Seq Age Sex Outcome Treatment
    1