BEUDAMED
    FDA Adverse Event Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 2602780 · Received May 29, 2012

    Report

    Report Number
    2027111-2012-00136
    Date Received
    May 29, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 29, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A F/U REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. LOT#: 1160764. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADD'L INFO, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAPAROSCOPIC CHOLECYSTECTOMY "SURGEON LOADED CLIP INTO JAWS AFTER PLACING IT THROUGH TROCAR AND BEFORE PLACING IT ON DUCT. WHILE PLACING THE CLIP ON DUCT THE CLIP FELL OUT OF THE JAWS ON THE CLIP APPLIER. MULTIPLE OTHER CLIPS WERE PLACED AND/OR DISCARDED. WHILE PLACING LAST CLIP A METAL PIECE PROTRUDED OUT UNDER THE JAWS AND NO CLIP WAS PRESENT. SURGEON STOPPED USING CLIP APPLIER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1164811

    Patients

    Seq Age Sex Outcome Treatment
    1