BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYONS DISSECTING FORCEPS

    MDR report key: 3201703 · Received June 28, 2013

    Report

    Report Number
    2183680-2013-00037
    Event Type
    Injury
    Date Received
    June 28, 2013
    Report Date
    June 12, 2013
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K031080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION CONFIRMED THE COMPLAINT - THE HUB IS FRACTURED. THE FRACTURE OCCURRED AT THE THIN TO THICK TRANSITION FEATURE OF THE HUB, FRACTURE SITE IS UNDER THE HEAT SHRINK. WHEN THE TWO PARTS WERE PLACED BACK TOGETHER ALL PARTS WERE ACCOUNTED FOR. FAILURE SUCH AS THESE HAVE BEEN ATTRIBUTED TO EXCESSIVE FORCE OR TORQUE BEING APPLIED TO THE DEVICE BEYOND ITS DESIGN INTENT. WE WILL CONTINUE TO MONITOR THE DATE BASE FOR FURTHER OCCURRENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE TIP OF THE PRODUCT BROKE WHILE USING IN A PT. NO INJURIES TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296971 LYONS DISSECTING FORCEPS LYONS DISSECTING FORCEPS GEI GYRUS MEDICAL INC. 3700 JF551314

    Patients

    Seq Age Sex Outcome Treatment
    1