BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE

    MDR report key: 2994035 · Received March 1, 2013

    Report

    Report Number
    2994035
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    January 23, 2013
    Report Date
    March 1, 2013
    Manufacturer
    COVIDIEN (FORMERLY KENDALL, 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

    SURGEON WAS USING THE DEVICE WHEN THE HANDLE LOCKED UP AND WOULD NOT WORK. CAUSED SLIGHT DELAY IN PROCEDURE, BUT NO ADVERSE EFFECT ON PATIENT; NO CHANGE IN PLAN OF CARE.======================MANUFACTURER RESPONSE FOR LAPAROSCOPIC SEALER/DIVIDER, LIGASURE ADVANCE MONOPOLAR TIP LAP SEALER/DIVIDER (PER SITE REPORTER).======================WE PLAN TO RETURN THE DEVICE TO THE REP FOR EVALUATION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HAD AN ATTEMPTED LAPAROSCOPIC SIGMOID COLECTOMY WITH CONVERSION TO OPEN SIGMOID COLECTOMY; CYSTOSCOPY AND PLACEMENT OF URETERAL CATHETER, LEFT URETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89472 LIGASURE ADVANCE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN (FORMERLY KENDALL, A DIVISION OF TYCO HEALTHCARE) 5MM-44CM 228533X

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NO OTHER THERAPIES