BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1903052 · Received November 12, 2010

    Report

    Report Number
    1717344-2010-00815
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 29, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    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 INCIDENT SAMPLE HAS BEEN REQUESTED, BUT TO DATE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL 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 A SMALL BOWEL RESECTION, THE DEVICE JAWS BECAME LOCKED ON TISSUE. WHILE REMOVING THE DEVICE, THE TISSUE BECAME TORN AND SUTURING WAS USED TO SEAL THE TISSUE. THERE WAS NO PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 191853L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK