BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2243784 · Received July 29, 2011

    Report

    Report Number
    1717344-2011-00632
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    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 THE JAWS OF THE INSTRUMENT COULD NOT BE RE-OPENED AND THE KNIFE BLADE WAS CONTAINED WITHIN THE JAWS. THE DEVICE WAS NOT ON TISSUE WHEN THIS OCCURRED. 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 LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 202282LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK