BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V 5 MM SEALER DIVIDER

    MDR report key: 2241589 · Received September 2, 2011

    Report

    Report Number
    3006451981-2011-00123
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 6, 2011
    Report Date
    August 18, 2011
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 EVAL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE DEVICE WOULD NO LONGER OPEN. THE DEVICE WAS EXCISED FROM TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO PT INJURY.

    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) S1EB013P

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK