BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKS LYONS

    MDR report key: 1191963 · Received October 3, 2008

    Report

    Report Number
    1191963
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 3, 2008
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PKS LYONS FORCEPS PACKAGE WAS OPENED TO THE SCRUB TECH WHO THEN HANDED IT TO THE SURGEON FOR PLACEMENT ON THE FIELD. A FEW MOMENTS LATER SHE TOOK THE INSTRUMENT AND PLACED IT IN ONE OF THE PORTS WHERE SHE COMMENCED USING IT TO RETRACT. BEFORE USING THE BIPOLAR INSTRUMENT TO CUT, SHE NOTICED THAT A PIECE OF THE TIP WAS MISSING. THE INSTRUMENT WAS REMOVED FROM THE FIELD AND REPLACED WITH ANOTHER. VISUAL EXAMINATION OF PATIENT'S ABDOMEN, THE STERILE FIELD, AND THE FLOOR WAS DONE. THE PIECE COULD NOT BE FOUND. IT WAS IN THE RIGHT MID ABDOMEN ON THE LEVEL OF L3. USING X-RAY THE PIECE WAS FOUND AND REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS LYONS FORCEPS, SURGICAL GEI OLYMPUS AMERICA, INC. * 8192083

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR NO OTHER THERAPIES| NO OTHER THERAPIES