BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK ENDO FASCIAL CLOSURE SYSEM

    MDR report key: 3050326 · Received April 8, 2013

    Report

    Report Number
    1044475-2013-00040
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 14, 2013
    Manufacturer
    TELEFLEX
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: THE EFX SUTURE PASSER TIP BROKE INSIDE THE PT'S ABDOMINAL WALL. THE DEVICE WAS USED FOLLOWING THE STANDARD IFU PROCEDURE AND WAS NOT USED OFF-LABEL. WHILE CLOSING THE FASCIAL PORT SITE USING THE EFX THE SUTURE PASSER WAS LOADED CORRECTLY AND INSERTED INTO THE DEVICE, HOWEVER WHILE REMOVING THE NEEDLE, THE NOTCHED PORTION 'CAUGHT' SOME OF THE FASCIAL TISSUE CAUSING THE NEEDLE TO 'TUG' BEFORE BREAKING IN THE PT'S ABDOMINAL WALL AT THE TIP WHERE THE NOTCHED PORTION FORMS A U-SHAPE. THE TIP WAS LOCATED AND RETRIEVED. THERE WAS NO INJURY TO THE PT OR TO THE USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142635 WECK ENDO FASCIAL CLOSURE SYSEM FASCIAL CLOSURE SYSTEM GCJ TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention