BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOLOK CLIPS LARGE

    MDR report key: 2032279 · Received March 29, 2011

    Report

    Report Number
    3003898360-2011-00048
    Event Type
    Death
    Date Received
    March 29, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 21, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K993157
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL SAMPLES INVOLVED IN INCIDENT ARE NOT AVAILABLE FOR INVESTIGATION. UNUSED SAMPLES FROM SAME LOT# BOX HAVE NOT BEEN RECEIVED BY MFR IN TIME FOR THIS REPORT, BUT WERE REPORTED AS AVAILABLE BY THE RISK COORDINATOR. INVESTIGATION IS INCOMPLETE. A F/U INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED. THE APPLIERS WHICH WERE USED WITH THE CLIPS WERE NOT ISOLATED, THEREFORE, THEY WILL NOT BE RETURNED FOR INVESTIGATION. THE U.F. NUMBER WAS UNRECOGNIZED, THEREFORE, THE ACTIVE USER FACILITY NUMBER ((B)(4)) IS BEING USED FOR THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    MEDWATCH RECEIVED. THE EVENT IS REPORTED AS: THE PT WAS A LIVING DONOR HAND ASSISTED NEPHRECTOMY. WECK HEM-O-LOK CLIPS WERE UTILIZED TO LIGATE THE RENAL ARTERY. APPROX 3 HOURS POST SURGERY, THE PT WENT INTO CARDIAC ARREST. THE PT WAS SENT TO THE OPERATING ROOM WHERE AN EXPLORATORY LAPAROTOMY WAS PERFORMED. THE PT WAS HEMORRHAGING AND IN SHOCK. THE PT EXPIRED IN THE OPERATING ROOM. IT WAS ALLEGED, THE CLIPS COULD BE SEEN FLOATING IN THE ABDOMINAL CAVITY WHICH WAS REPORTEDLY FULL OF BLOOD. THE CLIPS WERE CLOSED. THE HOSPITAL REPORTED AN AUTOPSY CONFIRMED THE "RENAL ARTERY WAS SURGICALLY CUT AND UNCLAMPED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOLOK CLIPS LARGE LIGATING CLIPS FZP TELEFLEX MEDICAL NA 01K1000203

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death