BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 3970173 · Received April 29, 2014

    Report

    Report Number
    1717344-2014-00376
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 4, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 EVALUATION. IF THE SAMPLE IS RECEIVED 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 THE JAWS OF THE DEVICE WOULD NOT LONGER OPEN DURING A LAPAROSCOPIC BILATERAL SALPINGO-OOPHERECTOMY. A NEW DEVICE WAS USED TO COMPLETE THE CASE AND THERE WAS NO PT INJURY. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256055 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYS GEI COVIDIEN LP 33500220X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK