BEUDAMED
    FDA Adverse Event Other Summary report: N

    WECK HEM-O-LOK CLIPS

    MDR report key: 1292204 · Received January 14, 2009

    Report

    Report Number
    3003898360-2009-00002
    Event Type
    Other
    Date Received
    January 14, 2009
    Report Date
    January 6, 2009
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TYPE OF REPORTABLE EVENT IS FOR MALFUNCTION AND SURGICAL INTERVENTION. SAMPLE DEVICE RECEIVED FOR EVALUATION. THE INVESTIGATION RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. INFORMATION IS NOT AVAILABLE, AT THE TIME OF THIS REPORT, TO INDICATE IF THE DEVICE WAS USED FOR A LAPAROSCOPIC DONOR NEPHRECTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. TELEFLEX MEDICAL STATES IN THE IFU THAT HEM-O-LOK LIGATING CLIPS ARE CONTRAINDICATED FOR USE IN LIGATING THE RENAL ARTERY DURING LAPAROSCOPIC DONOR NEPHRECTOMIES.

    Description of Event or Problem · 1

    THE INCIDENT WAS REPORTED AS; ABOUT TWO HOURS AFTER LAPAROSCOPIC NEPHRECTOMY, THE BLOOD PRESSURE OF THE PATIENT SUDDENLY DECREASED. AFTER IMMEDIATE RE-OPERATION, IT APPEARED THAT THE PATIENT HAD LOST APPROXIMATELY 3 LITERS OF BLOOD. THIS WAS CAUSED BY A BROKEN HEM-O-LOK CLIP, PER CUSTOMER REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEM-O-LOK CLIPS LIGATING CLIPS FZP TELEFLEX MEDICAL NA 01F0800296

    Patients

    Seq Age Sex Outcome Treatment
    1 NA