BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    33CM PKS CUTTING FORCEPS, 5MM

    MDR report key: 1457223 · Received June 23, 2009

    Report

    Report Number
    2183680-2009-00066
    Event Type
    Malfunction
    Date Received
    June 23, 2009
    Date of Event
    June 2, 2009
    Report Date
    June 23, 2009
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K023492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN DISCARDED BY THE FACILITY. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY. THE PK GENERATOR USED WITH THE DEVICE WAS FOUND TO PERFORM ACCORDING TO MFR'S SPECIFICATIONS, AS DESIGNED (PLEASE SEE MEDWATCH REPORT 2183680-2009-00065 FOR FURTHER INFO).

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE USING OUR CUTTING FORCEPS AND OUR PK GENERATOR, (B) (4), THE PT SUSTAINED A THERMAL INJURY. THE CUTTING FORCEPS, (B) (4), WERE DISCARDED AFTER THE PROCEDURE. THE PT WAS TREATED FOR THE BURN AND NO PROLONGED HOSPITALIZATION WAS REQUIRED. PLEASE SEE MEDWATCH REPORT #2183680-2009-00065 FOR THE DEVICE REPORT FOR THE PK GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 33CM PKS CUTTING FORCEPS, 5MM PKS CUTTING FORCEPS, 33CM, 5MM GEI GYRUS MEDICAL, INC. 3005PK3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1