BEUDAMED
    FDA Adverse Event Other Summary report: N

    WECK HEM-O-LOK ML ENDO MANUAL APPLIER

    MDR report key: 782761 · Received November 9, 2006

    Report

    Report Number
    1044475-2006-00018
    Event Type
    Other
    Date Received
    November 9, 2006
    Date of Event
    October 1, 2006
    Report Date
    November 9, 2006
    Manufacturer
    WECK, TELEFLEX MEDICAL
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE APPLIER WERE NOT REPORTED TO THE MANUFACTURING FACILITY TELEFLEX MEDICAL IS STILL AWAITING FOR PRODUCT RETURN TO BEGIN INVESTIGATION AND TO DETERMINE LOT NUMER. AT THIS TIME , TELEFLEX MEDICAL IS UNABLE TO PERFORM A DEVICE HISTORY RECORD REVIEW WITHOUT IDENTIFICATION OF THE LOT NUMBER. IF THE APPLIER IS RECEIVED, A DHR REVIEW AND EVALUATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TELEFLEX MEDICAL THAT, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON WAS ATTEMPTING TO LIGATE THE VESSEL WHEN THE APPLIER STOPPED FUNCTIONING. THE SURGEON WAS UABLE TO REMOVE THE APPLIER FORM THE CANNUAL AND WAS REQUIRED TO ENTER THROUGH AN EXISTING PROT TO ALIGN JAWS FOR REMOVAL. THE APPLIER WAS REMOVED WIHT MINIMAL ADDITIONAL. NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention