BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT THORACIC

    MDR report key: 2961021 · Received January 15, 2013

    Report

    Report Number
    1717344-2013-00029
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    November 26, 2012
    Report Date
    December 28, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE STOPPED SEALING AFTER USE DURING A LONG PROCEDURE. THE SURGEON OPENED ANOTHER INSTRUMENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. THE DEVICE WAS RETURNED WITH THE KNIFE BLADE EXPOSED. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21999 LIGASURE IMPACT THORACIC LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 232166LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK