BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT THORACIC

    MDR report key: 2961022 · Received January 15, 2013

    Report

    Report Number
    1717344-2013-00030
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    November 23, 2012
    Report Date
    November 26, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT THE DEVICE BLADE DID NOT RETRACT DURING AN OPEN COLORECTAL PROCEDURE. THERE WAS NO PT INJURY. THE SURGEON OPENED ANOTHER DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION WITH THE KNIFE BLADE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22160 LIGASURE IMPACT THORACIC LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP S2FF023X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK