BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEM-O-LOK ENDO 5

    MDR report key: 1052338 · Received May 23, 2008

    Report

    Report Number
    3003898360-2008-00032
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Report Date
    April 25, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SURGEON REPORTS THAT CLIP DID NOT LAUNCH, THE APPLIER MISFIRED AND JAMMED. NO PT INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEM-O-LOK ENDO 5 HEM-O-LOK GDO TELEFLEX MEDICAL T1206782

    Patients

    Seq Age Sex Outcome Treatment
    1