BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3210022 · Received June 27, 2013

    Report

    Report Number
    3006451981-2013-00208
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 6, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 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 THE PROCEDURE THE DEVICE WOULD NOT RE-OPEN WHILE APPLIED TO TISSUE, SO THE SURGEON RESECTED THE TISSUE IMMEDIATELY ADJACENT TO THE DEVICE IN ORDER TO REMOVE IT FROM THE TISSUE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293229 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S3AF006PX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK