BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYONS DISSECTING FORCEPS

    MDR report key: 2641732 · Received June 28, 2012

    Report

    Report Number
    2183680-2012-00034
    Event Type
    Injury
    Date Received
    June 28, 2012
    Report Date
    May 31, 2012
    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

    DURING THE INVESTIGATION THE DISSECTOR WAS FOUND WITH A FRACTURED HUB. THE FRACTURE SITE WAS UNDER THE HEAT SHRINK WHICH COVERS THE SHAFT OF THE DEVICE ALONG WITH THE PROXIMAL END OF THE HUB UP TO THE PIVOT RIVET. REMOVED THE HEAT SHRINK FROM THE DEVICE TO EXPOSE THE FRACTURED SITE, THE HUB BROKE IN HALF AT THE THIN TO THICK TRANSITION POINT OF THE HUB, JUST TO THE REAR OF THE PIVOT RIVET. WHEN THE TWO PIECES HAVE BEEN PLACED BACK TOGETHER, ALL PARTS ARE ACCOUNTED FOR. THESE TYPES OF FRACTURES HAVE ASSOCIATED WITH EXCESSIVE FORCE OR TORQUE BEING APPLIED TO THE DEVICE BY THE USER. WE WILL MONITOR THE COMPLAINT DATA BASE FOR FURTHER OCCURRENCES.

    Description of Event or Problem · 1

    GYRUSACMI WAS INFORMED THAT DURING A SURGICAL PROCEDURE, WHEN THE USER TRIED TO RETRACT THE KIDNEY, THE ROOT OF THE JAW FRACTURED. THE USER REPLACED IT WITH A NEW DEVICE, BUT THE NEW ONE ALSO FRACTURED WHEN HE TRIED TO TAKE THE SAME ACTION. NO PT INJURY WAS REPORTED (SEE MEDWATCH #2183680-2012-00035 FOR SECOND DEVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYONS DISSECTING FORCEPS LYONS DISSECTING FORCEPS GEI GYRUS MEDICAL, INC. 3700 366499ID

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK