BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT LF4318

    MDR report key: 3810436 · Received April 14, 2014

    Report

    Report Number
    1717344-2014-00243
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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 THE DEVICE INTERMITTENTLY ACTIVATED ON ITS OWN AND THAT THE BUTTON WAS STICKING. THERE WAS O INJURY TO THE PATIENT OR SURGICAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228347 LIGASURE IMPACT LF4318 LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 33540032X

    Patients

    Seq Age Sex Outcome Treatment
    1