BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1904218 · Received November 15, 2010

    Report

    Report Number
    1717344-2010-00854
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 3, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED, BUT TO DATE, HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D, 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 A DEBULKING PROCEDURE, THE JAWS LOCKED UP WHILE THE SURGEON WAS WORKING ON TISSUE BUNDLES DESCRIBED AS BEING VERY LARGE. THIS OCCURRED WITH TWO DIFFERENT DEVICES. THE OTHER DEVICE CAN BE REFERENCED ON MFR REPORT # 1717344-2010-00856. THERE WAS NO PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT NONE GEI COVIDIEN LP (VALLEYLAB) 193017L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK