BEUDAMED
    FDA Adverse Event Other Summary report: N

    33CM CUTTING FORCEPS, 5MM

    MDR report key: 1960288 · Received January 7, 2011

    Report

    Report Number
    2183680-2010-00057
    Event Type
    Other
    Date Received
    January 7, 2011
    Date of Event
    December 3, 2010
    Report Date
    January 7, 2011
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K023492
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GYRUSACMI CANNOT CONFIRM THE CUSTOMER COMPLAINT OF ACCIDENTAL ACTIVATION OF THE INSTRUMENT WITHOUT THE FOOT PETAL. THE DEVICE WAS TESTED AND FOUND TO WORK AS DESIGNED. THE DEVICE CAN ONLY BE ACTIVATED WITH A FOOT PETAL. THE CONNECTOR PLUG IS MOLDED SO THAT IT WILL ONLY FIT INTO THE INTENDED BI-POLAR CONNECTION OF THE GENERATOR AND CAN ONLY BE ACTIVATED WITH A FOOT SWITCH WHEN PROPERLY CONNECTED TO THE GENERATOR. CAUTION AND WARNING STATEMENTS REGARDING IMPROPER DEVICE CONNECTIONS AND SETTING WHICH MAY LEAD TO INADVERTENT DEVICE ACTIVATION CAN BE FOUND IN THE VALLEY LAB TRIAD USER MANUAL.

    Description of Event or Problem · 1

    DURING A PROCEDURE WHILE USING 3005 EVEREST MEDICAL CUTTING FORCEPS AND VALLEYLAB FORCE TRIAD GENERATOR, THE PATIENT WAS SUPERFICIALLY INTERNALLY BURNT WHEN THE GENERATOR ACCIDENTALLY ACTIVATED THE INSTRUMENT WITHOUT THE FOOTPETAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 33CM CUTTING FORCEPS, 5MM CUTTING FORCEPS GEI GYRUS MEDICAL, INC. 3005 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1