BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37 CM

    MDR report key: 2961773 · Received January 17, 2013

    Report

    Report Number
    3006451981-2013-00010
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 17, 2013
    Manufacturer
    COVIDIEN LLC F(SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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 REC'D 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 DEVICE WAS APPLIED TO TISSUE DURING A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND THE DEVICE JAWS COULD NOT BE RE-OPENED. THE SURGEON PRIED OFF THE DEVICE IN ORDER TO REMOVE IT. THERE WAS NO PT INJURY OR TISSUE DAMAGE REPORTED. THE SITE CONTACT WAS NOT ABLE TO PROVIDE ADD'L INFO REGARDING THE DEVICE OR INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27099 LIGASURE ATLAS HANDSWITCHING 37 CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC F(SHANGHAI) S2G0037X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK