BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM RATCHETED HANDLE 33CM

    MDR report key: 4251490 · Received November 14, 2014

    Report

    Report Number
    0002936485-2014-00913
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. DURING THE INSPECTION OF THE 5MM RATCHETED HANDLE 33CM, DINGS AND SCRATCHES WERE NOTICED THROUGHOUT THE SHAFT. ALSO, THERE WAS A CRACK SEEN NEAR THE DISTAL END OF THE SHAFT. IFU 10000401070 STATES "BEFORE USE, ENSURE THAT THERE ARE NO BREAKS, CHIPS, CRACKS, SCRATCHES, TEARS, OR MISSING/LOOSE COMPONENTS ON THE SHAFT INSULATION, HANDLE, OR HOUSING. DO NOT USE THE INSTRUMENT IF ANY OF THESE DEFECTS ARE PRESENT AS THIS COULD CAUSE UNINTENDED ELECTROSURGICAL BURNS AND LIFE-THREATENING COMPLICATIONS. IF DAMAGE HAS OCCURRED, DISCONTINUE USE AND RETURN THE INSTRUMENT FOR REPAIR OR REPLACEMENT." THE PROBABLE ROOT CAUSE/S COULD BE USER MISHANDLING OR IMPROPER STERILIZATION. 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
    737659 5MM RATCHETED HANDLE 33CM ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1