BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V 5 MM SEALER DIVIDER

    MDR report key: 3983212 · Received June 27, 2014

    Report

    Report Number
    3006451981-2014-00668
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF F/U REPORT: 08/05/2014. THE INCIDENT DEVICE WAS RETURNED, EVALUATED AND FOUND TO FUNCTION WITHIN SPEC. THE DEVICE WAS TESTED FOR ACTIVATION AND SEALING FUNCTION ON SIMULATED TISSUE WITH ACCEPTABLE RESULTS. ADD'L TESTING WAS DONE BY PERFORMING MULTIPLE SEALS OF VARIOUS SIZES ON PORCINE TISSUE AND ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY. COVIDIEN WAS UNABLE TO CONFIRM THE CUSTOMER'S REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A NEPHRECTOMY, ONLY THE SURFACE OF THE PT'S TISSUE APPEARED SEALED CORRECTLY EVEN THOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD. NO TISSUE DAMAGE. NO PT BLEEDING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377256 LIGASURE V 5 MM SEALER DIVIDER LIGASURE VESSEL SEALING SYS GEI COVIDIEN LLC (SHANGHAI) S3MB025X

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR