BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE PRECISE

    MDR report key: 1872495 · Received October 8, 2010

    Report

    Report Number
    1717344-2010-00690
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 13, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CUSTOMER REPORTED THAT VESSEL SEALING WAS NOT COMPLETED EVEN THOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD. THE SURGEON FELT THE EFFECT WAS HEATING AND NOT ACTUAL SEALING. ANOTHER DEVICE WAS USED WITH THE SAME RESULT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT TYPE OF LIGASURE DEVICE. THERE WAS NO PATIENT INJURY. ADDITIONAL DEVICE USED IN THE PROCEDURE CAN BE FOUND ON MFR. REPORT #1717344-2010-00689.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE PRECISE LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 182614

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK