BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 2851438 · Received October 31, 2012

    Report

    Report Number
    3006451981-2012-00186
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 11, 2012
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    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 IN THE MIDDLE OF A PROCEDURE, THE DEVICE STOPPED WORKING. OOZING OCCURRED ALTHOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO TISSUE DAMAGE AND NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S0MB003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK