BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 2070840 · Received April 15, 2011

    Report

    Report Number
    3006451981-2011-00059
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 22, 2011
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).. DATE OF INITIAL REPORT: (B)(4) 2011. THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVALUATION. IF THE SAMPLE IS REC'D OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A SMALL AMOUNT OF BLEEDING ALTHOUGH AN END TONE, INDICATING A COMPLETE SEAL CYCLE, WAS HEARD. THE SURGEON FELT THE INSTRUMENT WAS NOT FUNCTIONING AS IT NORMALLY DOES. HOWEVER, THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO BLOOD LOSS 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) SOHB030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK