BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V 5 MM SEALER DIVIDER

    MDR report key: 2132405 · Received June 13, 2011

    Report

    Report Number
    3006451981-2011-00078
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 19, 2011
    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 SAMPLE HAS BEEN REQUESTED BUT TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D, OR 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 A NEPHRECTOMY, THE DEVICE WOULD NO LONGER OPEN. THE SURGEON COULD EVENTUALLY REOPEN THE DEVICE TO REMOVE IT. THE SITE REPORTED OOZING OF UNDER 200CC. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE W/O INCIDENT. THERE WAS NO TISSUE DAMAGE AND NO PT INJURY. THE SITE WAS UNABLE TO PROVIDE MORE INFO AS TO WHETHER THE OOZING WAS DUE TO THE REMOVAL OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V 5 MM SEALER DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S1CB010X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK