BEUDAMED
    FDA Adverse Event Other Summary report: N

    WECK HEM-O-LOCK XL ENDO MANUAL APPLIER

    MDR report key: 752836 · Received July 28, 2006

    Report

    Report Number
    1044475-2006-00015
    Event Type
    Other
    Date Received
    July 28, 2006
    Date of Event
    January 1, 2006
    Report Date
    July 27, 2006
    Manufacturer
    WECK, 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

    LOT NUMBERS FOR THE APPLIERS WERE NOT REPORTED TO THE MANUFACTURING FACILITY. COMPLAINT WAS RECEIVED BY A DISTRIBUTOR THEREFORE LOT TRACING COULD NOT BE PERFORMED BY TELEFLEX MEDICAL. AT THIS TIME, TELEFLEX MEDICAL IS UNABLE TO PERFORM A DEVICE HISTORY RECORD REVIEW. IF THE APPLIER(S) ARE SENT IN, A DHR AND PRODUCT EVALUATION WILL BE PERFORMED AND A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TELEFLEX MEDICAL THAT DURING SURGICAL PROCEDURES, THE HEM-O-LOK XL CLIPS WERE NOT RELEASING FREELY FROM THE APPLIERS THAT WERE USED. SURGEON(S) WERE HAVING TO "JOGGLE" THE APPLIER JAWS TO RELEASE THE CLIPS. NO PATIENT INJURY REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEM-O-LOCK XL ENDO MANUAL APPLIER POLYMER LIGATION CLIP APPLIER GDO WECK, TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention