BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEM-O-LOK SMALL CLIPS

    MDR report key: 1052972 · Received May 27, 2008

    Report

    Report Number
    3003898360-2008-00035
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 30, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES RECENTLY RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED PENDING THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    INCIDENT REPORTED AS: THE SURGEON USED THIS DURING A CABG PROCEDURE FOR THE INTERNAL MAMMARY ARTERY TAKEDOWN. HE APPLIED 6 CLIPS. ONE CLIP FELL OFF IMMEDIATELY AFTER APPLICATION IN THE LOCKED POSITION. AN ADDITIONAL 2 CLIPS FELL OFF ABOUT 3-5 MINUTES AFTER THE APPLICATION. THESE CLIPS FELL OFF IN THE LOCKED POSITION. NO PATIENT INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEM-O-LOK SMALL CLIPS LIGATION CLIPS FZP TELEFLEX MEDICAL T1278090

    Patients

    Seq Age Sex Outcome Treatment
    1