BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE

    MDR report key: 2954000 · Received January 15, 2013

    Report

    Report Number
    2954000
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 15, 2013
    Manufacturer
    COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    DURING USE INSIDE THE PATIENT THE BLUE TIP END OF LIGASURE DISPOSABLE HAND PIECE BROKE OFF. THE BLUE TIP WAS REMOVED FROM THE PATIENT AND THE INSTRUMENT WAS REMOVED FROM THE SURGICAL FIELD.======================MANUFACTURER RESPONSE FOR MONOPOLAR TIP LAPAROSCOPIC SEALER/DIVIDER, LIGASUR ADVANCE (PER SITE REPORTER).======================PENDING.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC ROUX-EN-Y.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21896 LIGASURE ADVANCE ELECTROSURGICAL, COAGULATION, CUTTING GEI COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE LF5544 244998X

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR POSSIBLE THAT IT MAY HAVE COME IN CONTACT WITH ANO| THER LAPAROSCOPIC INSTRUMENT