BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 3062671 · Received March 21, 2013

    Report

    Report Number
    3062671
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 21, 2013
    Manufacturer
    COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH). THE HANDPIECE MALFUNCTIONED ON THE INITIAL USE, WAS SMOKING, GOT STICKY AND WOULD NOT RELEASE. A NEW HANDPIECE WAS RETRIEVED TO REPLACE DEFECTIVE HANDPIECE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAVH WITH BSO USING LIGASURE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116915 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE * 248293X

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR