BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT THORACIC

    MDR report key: 3002670 · Received February 13, 2013

    Report

    Report Number
    1717344-2013-00087
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 6, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DURING A PROSTATECTOMY, THE DEVICE JAWS COULD NOT BE RE-OPENED. THE SURGEON MANUALLY REMOVED THE JAWS FROM THE TISSUE. THE CUSTOMER REPORTED THAT DURING THE REMOVAL THE TISSUES WERE SLIGHTLY DAMAGED BUT THER WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63957 LIGASURE IMPACT THORACIC LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 220749LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK