BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE SMALL JAW

    MDR report key: 3940445 · Received April 17, 2014

    Report

    Report Number
    1717344-2014-00334
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 17, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 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 THE DEVICE DID NOT COMPLETE TWO COMPLETE SEALS DURING A THYROIDECTOMY. AN END TONE WAS PROVIDED BY THE GENERATOR IN USE, INDICATING THAT A COMPLETE SEAL CYCLE, WAS MADE. THE BLEEDING WAS DESCRIBED AS MINOR AND WAS STOPPED USING AN ELECTROSURGICAL PENCIL. THE SURGEON CONTINUED USING THE DEVICE IN ORDER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL BLEEDING AREAS WERE OBSERVED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235942 LIGASURE SMALL JAW LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK