BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM RATCHETED HANDLE 33CM

    MDR report key: 3930156 · Received July 11, 2014

    Report

    Report Number
    0002936485-2014-00470
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 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 SHOWED DENTS ON THE SHAFT'S INSULATION FUNCTIONAL INSPECTION : THE 5MM RATCHETED HANDLE 33CM WAS TESTED WITH AND INSULSCAN AND FAILED. PROBABLE ROOT CAUSES COULD BE USER MISUSE; USER EXCESSIVE FORCE; IMPROPER CLEANING AND STERILIZATION; NORMAL WEAR. 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
    406755 5MM RATCHETED HANDLE 33CM ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 1045684D

    Patients

    Seq Age Sex Outcome Treatment
    1