BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT THORACIC

    MDR report key: 3023399 · Received February 26, 2013

    Report

    Report Number
    1717344-2013-00109
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Report Date
    January 24, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT THE BLADE OF THE INSTRUMENT WOULD NOT PROTRACT OR RETRACT DURING THE PROCEDURE. THERE WAS NO PT INJURY REPORTED DURING THE INCIDENT. THE SITE CONTACT INDICATED THAT NO ADDITIONAL INFORMATION WAS AVAILABLE REGARDING THE DEVICE OR INCIDENT. THE DEVICE WAS RETURNED FOR EVAL WITH THE KNIFE BLADE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83494 LIGASURE IMPACT THORACIC LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK