BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT THORACIC

    MDR report key: 2902038 · Received November 27, 2012

    Report

    Report Number
    3006451981-2012-00222
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 REPORTED THAT DURING AN ABDOMINOPLASTY, THE DEVICE JAWS COULD NOT BE RE-OPENED WHILE APPLIED TO TISSUE. THE SURGEON MANUALLY REMOVED THE INSTRUMENT WITH NO TISSUE DAMAGE OR PT INJURY. THE SURGEON OPENED ANOTHER INSTRUMENT TO CONTINUE THE PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION 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 LLC (SHANGHAI) S2DF002X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK