BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFX WECK

    MDR report key: 6521779 · Received April 26, 2017

    Report

    Report Number
    6521779
    Event Type
    Malfunction
    Date Received
    April 26, 2017
    Date of Event
    April 12, 2017
    Report Date
    April 24, 2017
    Manufacturer
    TELEFLEX INCORPORATED
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, CYSTO, LYSIS OF ADHESIONS, THE EFX SHIELD MALFUNCTIONED. ANOTHER ONE WAS OBTAINED AND THAT ONE ALSO FAILED. THE REP FROM THE COMPANY TOOK THE TWO ITEMS, BOTH WITH THE SAME LOT NUMBER. ANOTHER MANUFACTURER'S CLOSURE DEVICE WAS THEN USED TO CLOSE THE FASCIA AFTER THE TWO FAILED ATTEMPTS WITH THE EFX SHIELD. THERE WAS NO PATIENT HARM. MANUFACTURER RESPONSE FOR INSTRUMENT, LIGATURE PASSING AND KNOT TYING, WECK (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304320 EFX WECK INSTRUMENT, LIGATURE PASSING AND KNOT TYING GCJ TELEFLEX INCORPORATED IPN011977 3280600000

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR NO,| NOT APPLICABLE.