BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT THORACIC

    MDR report key: 3032018 · Received March 6, 2013

    Report

    Report Number
    3006451981-2013-00056
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 20, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    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 INFORMATION 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 HYSTERECTOMY, THE DEVICE JAWS COULD NOT BE RE-OPENED WHILE APPLIED TO A LIGAMENT AND THE KNIFE IS REPORTED AS PROTRUDING FROM THE JAWS. THE SURGEON MANUALLY REMOVED THE INSTRUMENT FROM THE PATIENT'S TISSUE. THE SURGEON OPENED A NEW DEVICE IN ORDER TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96415 LIGASURE IMPACT THORACIC LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2FF08X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK