BEUDAMED
    FDA Adverse Event Other Summary report: N

    LYONS DISSECTING FORCEPS

    MDR report key: 2273665 · Received September 23, 2011

    Report

    Report Number
    2183680-2011-00031
    Event Type
    Other
    Date Received
    September 23, 2011
    Date of Event
    July 21, 2011
    Report Date
    September 23, 2011
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K031080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    GYRUS ACMI, INC. RECEIVED A MAUDE EVENT REPORT GIVING US VERY LITTLE INFO REGARDING THIS COMPLAINT. AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    FEMALE ADMITTED FOR A LAPAROSCOPIC PROCEDURE, DURING SURGERY A PIECE OF THE JAW FROM THE DEVICE BROKE OFF IN THE PT. THE PT WAS LOCATED USING A C-ARM XRAY AND WAS REMOVED. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYONS DISSECTING FORCEPS LYONS DISSECTING FORCEPS GEI GYRUS MEDICAL INC. 942005PK

    Patients

    Seq Age Sex Outcome Treatment
    1