BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V 5MM SEALER DIVIDER

    MDR report key: 1935669 · Received December 16, 2010

    Report

    Report Number
    3006451981-2010-00108
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 29, 2010
    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 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 JAWS WOULD NO LONGER OPEN. THE JAWS WERE REMOVED FROM TISSUE WITH SOME TISSUE DAMAGE. THERE WAS NO BLEEDING AND NO PT INJURY. NO FURTHER INFO ON HOW THE DEVICE WAS REMOVED WAS AVAILABLE FROM THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V 5MM SEALER DIVIDER LIGASURE V VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S0BG003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK