BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEM-O-LOK ENDOSCOPIC 10MM XL APPLIER

    MDR report key: 1760827 · Received July 14, 2010

    Report

    Report Number
    1044475-2010-00076
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 17, 2010
    Report Date
    June 28, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: NOT ENOUGH PRESSURE IN THE JAWS TO CLOSE THE CLIPS. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEM-O-LOK ENDOSCOPIC 10MM XL APPLIER HEM-O-LOK ENDO APPLIER GDO TELEFLEX MEDICAL NA 2434828-024

    Patients

    Seq Age Sex Outcome Treatment
    1