BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 2903729 · Received January 2, 2013

    Report

    Report Number
    1717344-2012-01271
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 21, 2012
    Report Date
    December 5, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVAL. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED. ADD'L DATA FROM USER FACILITY REPORT: BRAND NAME - LIGASURE, COMMON DEVICE NAME - BLUNT TIP LAPAROSCOPIC INSTRUMENT, (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE DEVICE WOULD NOT OPEN WHILE ON TISSUE/BLOOD VESSEL. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. ADD'L DATA FROM USER FACILITY REPORT: MALFUNCTION CAUSED BY TIP NOT OPENING AND RELEASING TISSUE BLOOD VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other