BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1874096 · Received October 15, 2010

    Report

    Report Number
    1717344-2010-00686
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 21, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(4) 2010. THE SITE INDICATED THAT THE INCIDENT SAMPLE WAS DISCARDED. THE INCIDENT GENERATOR IS BEING EVALUATED. IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN OPEN RIGHT COLON PROCEDURE, THE DEVICE DID NOT SEAL EVEN THOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD. THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FORCE TRIAD ENERGY PLATFORM: (B)(4)