BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEM-O-LOK SMALL CLIPS

    MDR report key: 1052971 · Received May 27, 2008

    Report

    Report Number
    3003898360-2008-00034
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 1, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 SMALL CLIPS WERE USED IN A CABG PROCEDURE TO LIGATE THE BRANCHES OF THE IMA AND SAPHENOUS VEIN. CLIPS HAD DIFFICULTY CLOSING ON THE IMA BRANCHES, THUS REQUIRING SEVERAL ATTEMPTS TO CLIP BEFORE IT WOULD LOCK. TWO CLIPS BECAME DISLODGED WHEN HANDLING THE VEIN AND DURING THE ANASTOMOSIS. CLIPS WERE REAPPLIED AND APPEARED TO HOLD FIRMLY. NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1