BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3810456 · Received April 15, 2014

    Report

    Report Number
    1717344-2014-00318
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 17, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE KNIFE IS TRAPPED AND CONTAINED WITHIN THE JAWS, WHICH KEPT THE JAWS FROM OPENING. THIS CAN OCCUR WHEN THE BLADE IS EXTENDED AND THE JAWS ARE NOT COMPLETELY CLOSED. THIS ALLOWS THE KNIFE TRACK TO OPEN TOO WIDE AND THE BLADE MOVES OUT OF ITS TRACK. THE IFU CAUTIONS TO CONFIRM THAT THE JAWS HAVE REACHED THE CLOSED POSITION AND ARE LOCKED (THE HANDLE IS LATCHED) BEFORE ACTIVATING THE CUTTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HANDLE OF THE DEVICE LOCKED AFTER 1 MINUTE OF USER DURING A RIGHT SIDE HEMICOLECTOMY PROCEDURE. THERE WAS NO INJURY TO THE PT. NO FURTHER DETAILS HAVE BEEN MADE AVAILABLE BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230808 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 33430147X

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR