BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 33CM PEEK MONOPOLAR HANDLE 33CM

    MDR report key: 3083674 · Received April 29, 2013

    Report

    Report Number
    0002936485-2013-00188
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. ALSO THE INSULATION IS MELTED NEAR THE DISTAL TIP. THE INSULATION WAS TESTED FOR CRACKS/DAMAGES AND 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 WAS COMPROMISED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185284 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE ¿0443871C¿

    Patients

    Seq Age Sex Outcome Treatment
    1