BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 2990184 · Received February 6, 2013

    Report

    Report Number
    3006451981-2013-00030
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    December 6, 2012
    Report Date
    January 22, 2013
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 ADD¿L 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 A LOBECTOMY, WHEN SEALING ON FATTY TISSUE, OOZING OCCURRED ALTHOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD. CAUTERY WAS USED TO STOP THE OOZING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO TISSUE DAMAGE, NO BLEEDING AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51215 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC S2HB025X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK