BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3931195 · Received June 17, 2014

    Report

    Report Number
    3931195
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    March 31, 2014
    Report Date
    June 16, 2014
    Manufacturer
    COVIDIEN LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE LIGASURE HANDPIECE ACTIVATED SEALER/DIVIDER LOCKED CLOSED ON SURGEON. DEVICE WOULD NOT REOPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356206 LIGASURE IMPACT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN LLC * 2780955

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR