BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 33CM PEEK MONOPOLAR HANDLE 33CM

    MDR report key: 4090353 · Received September 15, 2014

    Report

    Report Number
    0002936485-2014-00713
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 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. DURING THE INSPECTION OF THE 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM IT WAS CONFIRMED, THE INSULATION IS COMPROMISED. VISIBLE DINGS AND SCRATCHES THROUGHOUT THE SHAFT AND SEPARATION OF THE INSULATION AT THE PROXIMAL AND DISTAL END WERE SEEN. ALSO IT WAS NOTICED THAT THIS UNIT COULD HAVE POSSIBLY BEEN REPAIRED BY A THIRD PARTY IN THE PAST. THE 5MM, 33CM PEEK MONOPOLAR HANDLE 33CMIS MISSING THE STRYKER ETCHING AT THE PROXIMAL END OF THE SHAFT, WHICH CONSIST OF LOT NUMBER, CE MARK, US PAT NO AND THE REFERENCE NUMBER. THE 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM FAILED THE INSULATION INTEGRITY TEST. IFU 1000401070 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 COULD BE WEAR AND TEAR AND OR MISHANDLING. IN SUM, THE PRODUCT 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
    568964 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 08252014

    Patients

    Seq Age Sex Outcome Treatment
    1