BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT THORACIC

    MDR report key: 3090137 · Received April 19, 2013

    Report

    Report Number
    3006451981-2013-00118
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    April 8, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. 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 THE FIRST APPLICATION OF THE DEVICE, THE JAWS COULD NOT BE RE-OPENED WHILE APPLIED TO TISSUE. ADDITIONAL QUESTIONS HAVE BEEN ASKED RELATING TO THE DEVICE AND INCIDENT. TO DATE, THE SITE CONTACT HAS NOT PROVIDED ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169505 LIGASURE IMPACT THORACIC LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S3AF031PX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK