BEUDAMED
    FDA Adverse Event Other Summary report: N

    LYONS DISSECTING FORCEPS

    MDR report key: 2434655 · Received January 27, 2012

    Report

    Report Number
    2183680-2012-00003
    Event Type
    Other
    Date Received
    January 27, 2012
    Date of Event
    December 12, 2011
    Report Date
    January 4, 2012
    Manufacturer
    GYRUS MEDICAL INC
    Product Code
    GEI
    PMA / PMN Number
    K031080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED, DEVICE RECEIVED WITH THE HUB FRACTURED, FRACTURED UNDER THE HEAT SHRINK, THE JAWS OF THE DEVICE ALSO APPEAR BENT, REMOVED THE HEAT SHRINK TO EXPOSE THE HUB, WHEN THE TWO PARTS ARE PLACED BACK TOGETHER ALL PARTS ARE ACCOUNTED FOR, THE JAWS APPEAR TO HAVE BEEN TORQUE OR TWISTED IN SUCH A MANNER THAT THEY ARE BENT, THE ENDS OR TIPS OF THE JAWS TO NOT MEET TOGETHER CORRECTLY, FRACTURES OF THE HUBS HAVE IN THE PAST BEEN ATTRIBUTED TO THE JAWS OF THE DEVICE BEING EXPOSED TO EXCESSIVE FORCE, THE BENDING OR DISTORTION OF THE JAWS ARE INDICATIVE TO THIS TYPE OF ROTATIONAL TORQUE OR FORCE BEING APPLIED TO THE DEVICE. WE WILL CONTINUE TO MONITOR THE DATA BASE FOR FURTHER OCCURRENCES. THE FAILURE MODE IS NOT RELATED TO THE MFR OF THE DEVICE, IT IS CLASSIFIED AS MISUSE.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE THE FORCEPS BROKE IN THE PT WHEN USING IN THE ABDOMINAL CAVITY. ALL PARTS REMAINED ATTACHED TO THE DEVICE. NO HARM OR LONGER STAY FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYONS DISSECTING FORCEPS DISSECTOR FORCEPS GEI GYRUS MEDICAL INC 3700 355207HD

    Patients

    Seq Age Sex Outcome Treatment
    1