BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V 5 MM SEALER DIVIDER

    MDR report key: 1232074 · Received November 7, 2008

    Report

    Report Number
    1717344-2008-00516
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT SEALS WITH THE DEVICE WERE NOT AS CONSISTENT AS PREVIOUSLY EXPERIENCED BY THE SURGEON. THE SURGEON FELT THE ACTIVATION BUTTON BEHAVED ERRATICALLY, SOMETIMES BEING OVERLY SENSITIVE AND OTHER TIMES REQUIRING THE SURGEON TO PRESS EXTRA HARD TO ACTIVATE THE DEVICE. THE REGRASP ALARM ALSO WENT OFF REGULARLY. THERE WAS MINOR BLEEDING AND OOZING, BUT NO PATIENT INJURY WAS REPORTED. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V 5 MM SEALER DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 144167

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR COVIDIEN FORCETRIAD ENERGY PLATFORM: SN UNK