BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 33CM PEEK MONOPOLAR HANDLE 33CM

    MDR report key: 3080415 · Received April 26, 2013

    Report

    Report Number
    0002936485-2013-00173
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. DENTS AND SCRATCHES WERE SEEN ON THE INSULATION. THE INSULATION WAS TESTED FOR CRACKS/DAMAGES, THE INSULATION FAILED THE INSULATION SCAN TEST. THE PROBABLE ROOT CAUSES ARE USER MISUSE, IMPROPER STERILIZATION METHODS, AND/OR NORMAL WEAR. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    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 OF THE DEVICE IS COMPROMISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION OF THE DEVICE IS COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182678 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 0943287D

    Patients

    Seq Age Sex Outcome Treatment
    1