BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEM-O-LOK ENDO5

    MDR report key: 1071737 · Received July 9, 2008

    Report

    Report Number
    3003898360-2008-00047
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 23, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REQUESTED. AT THE TIME OF THIS REPORT, THE DEVICE SAMPLE HAD NOT BEEN REC'D FOR EVAL. A FOLLOW-UP REPORTED WILL BE PROVIDED, ONCE THE DEVICE SAMPLE IS REC'D, AND/OR AT CONCLUSION OF INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE CLIP APPLIER BLOCKED DURING OPERATION. NO PT INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEM-O-LOK ENDO5 HEM-O-LOK GDO TELEFLEX MEDICAL 01K0700005

    Patients

    Seq Age Sex Outcome Treatment
    1