BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO PKS CUTTING FORCEPS

    MDR report key: 2214036 · Received August 3, 2011

    Report

    Report Number
    2183680-2011-00030
    Event Type
    Other
    Date Received
    August 3, 2011
    Date of Event
    June 9, 2011
    Report Date
    August 3, 2011
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS COULD NOT CONFIRM THE CUSTOMER'S COMPLAINT OF "SURGEON BEING SHOCKED DURING THE USE OF THE HALO AND GENERATOR." TESTED THE HALO WITH THE CUSTOMERS GENERATOR AND FOUND THAT THE DEVICE ACTIVATED AND COAGULATED AS DESIGNED WITH NO ELECTRICAL SHOCK EXPERIENCED DURING THE TESTING OF THE HAND PIECE AND GENERATOR. THE GENERATOR WAS INSPECTED AND TESTED AND FOUND TO OPERATE TO THE MFR'S SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING A PROCEDURE WHILE USING THE G400 GENERAL SURGERY WORKSTATION AND HALO CUTTING FORCEPS, (SEE MFR REPORT #9617070-2011-00004 FOR G400 WORKSTATION) THE SURGEON GOT SHOCKED UP TO HIS ELBOW. NO OTHER HARM DONE. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO PKS CUTTING FORCEPS HALO PKS CUTTING FORCEPS GEI GYRUS MEDICAL INC. HACF0533

    Patients

    Seq Age Sex Outcome Treatment
    1