BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 33CM PEEK MONOPOLAR HANDLE 33CM

    MDR report key: 3930175 · Received July 11, 2014

    Report

    Report Number
    0002936485-2014-00476
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    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

    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 THAT THE INSULATION IS COMPROMISED. VISIBLE DINGS AND SCRATCHES WERE SEEN THROUGHOUT THE SHAFT. THE 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM PASSED THE INSULSCAN TEST. THE PROBABLE ROOT CAUSE COULD BE USER MISHANDLING AND OR WEAR AND TEAR. 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
    406439 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 1245057H

    Patients

    Seq Age Sex Outcome Treatment
    1