BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USA ELITE RIGID OPTICAL GRASPING FORCEPS

    MDR report key: 3133513 · Received May 24, 2013

    Report

    Report Number
    1519132-2013-00013
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 OF THE JAW AT THE DISTAL TIP. THE JAW WAS NOT RETURNED WITH INSTRUMENT. THE BALANCE OF THE INSTRUMENT IS IN GOOD PHYSICAL CONDITION. THE FAILURE OF THIS INSTRUMENT WAS LIKELY CAUSED BY EXCESSIVE FORCE EXERTED BY THE CUSTOMER DURING USE. THE EVIDENCE OF TORN METAL AT THE BREAK SITE NOTED IN THE INVESTIGATION SUPPORTS THIS CONCLUSION. IT MUST ALSO BE NOTED THAT THE IFU WARNS AGAINST THIS MISUSE IN THE CAUTIONS SECTION AS FOLLOWS. EXCESSIVE SQUEEZING FORCE ON HANDLES CAN LEAD TO FAILURE OF FORCEPS JAWS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GYRUSACMI THAT DURING A SURGICAL PROCEDURE THE JAW SNAPPED OFF INSIDE THE PT'S BLADDER. THE PIECE WAS RETRIEVED AND THERE WAS NO PT HARM OR INJURY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232157 USA ELITE RIGID OPTICAL GRASPING FORCEPS RIGID OPTICAL GRASPING FORCEPS GEN GYRUS ACMI, INC. E8215

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK