BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE

    MDR report key: 3110600 · Received May 6, 2013

    Report

    Report Number
    3110600
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    March 8, 2013
    Report Date
    May 6, 2013
    Manufacturer
    COVIDIEN FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MD REPORTED THAT DEVICE KEPT LOCKING. SPECIFICALLY, THE KNIFE BLADE BECAME STUCK AND THE TRIGGER WOULD NOT MOVE. AS A RESULT, THERE WAS A MINOR DELAY IN CASE RELATED TO OPENING ANOTHER DEVICE. NO HARM OR INJURY TO PATIENT; PROCEDURE COMPLETED.======================MANUFACTURER RESPONSE FOR LIGASURE MONOPOLAR TIP, LIGASURE MONOPOLAR TIP/ COVIDIEN LIGASURE ADVANTAGE (PER SITE REPORTER).======================HAVE NOT HEARD BACK ON THIS DEVICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197720 LIGASURE ADVANCE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE * 228533

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR PT UNDERGOING A LAP ASSITED VAGINAL HYSTERECTOMY