BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT THORACIC

    MDR report key: 2231312 · Received July 25, 2011

    Report

    Report Number
    1717344-2011-00614
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 20, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED 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 ORIGINALLY REPORTED THAT THE INSTRUMENT JAWS COULD NOT BE OPENED AND WAS NOT IN CONTACT WITH THE PATIENT. THE SURGEON OPENED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE DEVICE WAS RETURNED WITH THE KNIFE BLADE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT THORACIC LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 208569LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK