BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK EFX

    MDR report key: 3302395 · Received August 9, 2013

    Report

    Report Number
    3302395
    Event Type
    Malfunction
    Date Received
    August 9, 2013
    Date of Event
    August 5, 2013
    Report Date
    August 9, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    DURING SITE CLOSURE THE TIP OF THE SUTURE PASSER BROKE OFF. UNDER FLUOROSCOPY THE TIP (3 MM DIAMETER) WAS CONFIRMED TO BE IN THE SUBCUTANEOUS TISSUES. THE MD ELECTED TO LEAVE THE TIP IN PLACE, AS RETRIEVAL WOULD REQUIRE A LARGER INCISION AND POSSIBLY DAMAGE THE SURROUNDING MUSCLE TISSUE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC SLEEVE GASTRECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379225 WECK EFX ENDO FASCIAL CLOSURE SYSTEM GCJ TELEFLEX MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR