BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM, 33CM PEEK MONOPOLAR HANDLE

    MDR report key: 2860748 · Received October 30, 2012

    Report

    Report Number
    2936485-2012-00533
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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 ON THE UNIT HAS BEEN COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10MM, 33CM PEEK MONOPOLAR HANDLE KOG STRYKER ENDOSCOPY SAN JOSE 0944142D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK