BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK EFX

    MDR report key: 4124624 · Received September 15, 2014

    Report

    Report Number
    4124624
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CLOSURE OF A LAPAROSCOPIC PORT FOLLOWING A LAP HYSTERECTOMY, THE CLOSURE DEVICE NEEDLE BENT AT A 90 DEGREE WHILE GOING THROUGH THE FASCIA. UPON REMOVAL OF THE NEEDLE, IT BROKE AND THE SHARP END FELL INTO THE ABDOMINAL CAVITY. IT IS APPROXIMATELY ¿ OF AN INCH LONG. THEY WERE UNABLE TO RETRIEVE THE NEEDLE. A GENERAL SURGEON WAS CONSULTED AND HE ADVISED THAT THEY DO NOT OPEN THE ABDOMEN AND TO LEAVE THE SHARP IN THE PATIENT. ====================== MANUFACTURER RESPONSE FOR FASCIAL CLOSURE SYSTEM, WECK ENDO FASCIAL CLOSURE SYSTEM (PER SITE REPORTER)======================NONE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570338 WECK EFX INSTRUMENT, LIGATURE PASSING GCJ TELEFLEX MEDICAL * EF038958

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR