BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2902039 · Received November 27, 2012

    Report

    Report Number
    1717344-2012-01185
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Report Date
    October 24, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    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 A CYSTECTOMY, 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 DEVICE 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 LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 221928LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK