BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2990192 · Received February 6, 2013

    Report

    Report Number
    3006451981-2013-00031
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 21, 2013
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADD¿L 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 COULD NOT BE RE-OPENED AND THE KNIFE BLADE WOULD NOT RETRACT. THE SITE CONTACT WAS NOT ABLE TO PROVIDE INFO AS TO WHETHER THE DEVICE WAS APPLIED TO TISSUE WHEN THIS OCCURRED OR NOT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50796 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC S2HF040X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK