BEUDAMED
    FDA Adverse Event Other Summary report: N

    LYONS PLASMAKINETIC DISSECTING FORCEPS

    MDR report key: 2483282 · Received February 29, 2012

    Report

    Report Number
    2183680-2012-00012
    Event Type
    Other
    Date Received
    February 29, 2012
    Date of Event
    January 20, 2012
    Report Date
    January 31, 2012
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K031080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CURRENTLY STILL UNDER INVESTIGATION AND TESTING AT OUR FACILITY. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. WHEN FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GYRUSACMI THAT DURING A THERAPEUTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE TIP OF TWO UNITS BROKE INSIDE THE ABDOMEN BUT REMAINED INTACT ON THE HANDPIECE. AS A RESULT, THE SURGEON DID NOT HAVE TO RETRIEVE ANY BROKEN PIECES. THE SURGEON OPENED A THIRD LYON'S FORCEP WITH THE SAME LOT NUMBER AS THE TWO BROKEN DEVICES AND COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT. (SEE MDR # 2183680-2012-00011 FOR SECOND DEVICE.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYONS PLASMAKINETIC DISSECTING FORCEPS DISSECTING FORCEPS GEI GYRUS MEDICAL INC. 942005PK 355208HD

    Patients

    Seq Age Sex Outcome Treatment
    1