BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1062798 · Received June 17, 2008

    Report

    Report Number
    1717344-2008-00271
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 19, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    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 WITH AN ABTOT WHILE SEALING THE ADNEXA, THE FIRST OF TWO LIGASURE IMPACTS COULD NOT BE OPENED AFTER THE 3RD APPLICATION. THERE APPEARED TO BE NEITHER TOO MUCH TISSUES IN THE JAWS NOR ANY CONTRAINDICATION ON THE PART OF THE PATIENT. THE TISSUES HAD TO BE RELEASED BY FORCE FROM THE INSTRUMENT BUT DID NOT BLEED STRONGLY. WITH THE SECOND LIGASURE IMPACT (REPORTED ON COMPLAIN, REPORT # 1717344-2008-00271), THE OMENTUM MAJOR WAS SEALED BUT AFTER A FEW SECONDS IT BLED FROM THE SEALED AREA AND THE SURGEON HAD TO COAGULATE IT WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 132135

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FORCETRIAD-ENERGY PLATFORM (ES GENERATOR)