BEUDAMED
    FDA Adverse Event Other Summary report: N

    USA ELITE RIGID OPTICAL GRASPING FORCEPS

    MDR report key: 2249681 · Received August 24, 2011

    Report

    Report Number
    1519132-2011-00023
    Event Type
    Other
    Date Received
    August 24, 2011
    Report Date
    August 24, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE INSTRUMENT CONFIRMS THAT THE DEVICE HAS FAILED DUE TO BREAKAGE OF THE RIGHT SIDE JAW AT THE PROXIMAL JOINT OF THE COMPONENT. THE JAW WAS NOT RETURNED WITH INSTRUMENT. CLOSE INSPECTION OF THE BREAK SITE INDICATES MATERIAL FAILURE OF THE JAW COMPONENT OCCURRED. THERE IS NO EVIDENCE OF ANY PREEXISTING DAMAGE OR FATIGUE OF THE MATERIAL. THE HANDLE OF THE DEVICE HAS A STAMP OR MARK, POSSIBLY INDICATING THIRD PARTY INVOLVEMENT. THE BALANCE OF THE INSTRUMENT IS IN GOOD PHYSICAL CONDITION WITH NO SIGNS OF ABUSE OR WEAR AND TEAR. THE FAILURE OF THIS INSTRUMENT WAS LIKELY CAUSED BY EXCESSIVE FORCE EXERTED BY THE CUSTOMER DURING USE. THE DAMAGE SITE IS CONSISTENT WITH THAT OF PREVIOUS RETURNED INSTRUMENTS, WHICH HAVE BEEN DETERMINED TO BE CAUSED BY THE SAME CONDITIONS. IT IS UNCLEAR IF THE INVOLVEMENT OF A THIRD PARTY REPAIR HAD ANY INFLUENCE ON THE FAILURE.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE WHILE USING THE USA ELITE RIGID OPTICAL GRASPING FORCEPS, THE GRASPER TIP BROKE OFF AND FELL INTO THE PATIENT. THE PATIENT WAS ABLE TO PASS IT DURING RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USA ELITE RIGID OPTICAL GRASPING FORCEPS GRASPING FORCEPS FCL GYRUS ACMI, INC. E8215

    Patients

    Seq Age Sex Outcome Treatment
    1