BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 2902075 · Received November 28, 2012

    Report

    Report Number
    3006451981-2012-00219
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    October 23, 2012
    Report Date
    November 9, 2012
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 WHILE SEALING THE SUPRARENAL PEDICLE THE DEVICE WOULD NO LONGER OPEN. OOZING OF LESS THAN 250CC OCCURRED WHEN REMOVING THE DEVICE FROM THE TISSUE. ANOTHER DEVICE WAS USED TO STOP THE OOZING AND COMPLETE THE SURGERY W/O INCIDENT. THERE WAS NO ISSUE DAMAGE AND NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S1KB807X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK