BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLOK 5MM ENDO APPLIER ML

    MDR report key: 3193097 · Received June 21, 2013

    Report

    Report Number
    1044475-2013-00085
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 3, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE RETURNED TO MFR, BUT INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: SURGEON UNABLE TO RELEASE CLIP FROM THE JAW AFTER LIGATING THE VESSEL DURING A LAPAROSCOPIC CHOLECYSTECTOMY. NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283001 HEMOLOK 5MM ENDO APPLIER ML LIGATING APPLIER GDO TELEFLEX MEDICAL 04J0800157

    Patients

    Seq Age Sex Outcome Treatment
    1