BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 2060676 · Received April 8, 2011

    Report

    Report Number
    1717344-2011-00276
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL EXAMINATION OF THE INCIDENT DEVICE REVEALED TISSUE BETWEEN THE JAWS, BUT THE JAWS WERE NOT STUCK SHUT. THE DEVICE WAS FOUND TO FUNCTION WITHIN SPEC. ADD'L TESTING WAS DONE BY PERFORMING MULTIPLE SEALS OF VARIOUS SIZES ON PORCINE TISSUE AND ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY. THE IFU FOR THIS DEVICE STATES KEEP THE INSTRUMENT JAWS CLEAN. A BUILD-UP OF ESCHAR MAY REDUCE SEALING AND/OR CUTTING EFFECTIVENESS. WIPE JAW SURFACES AND EDGES WITH A WET GAUZE PAD AS NEEDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AT THE BEGINNING OF A HEMICOLECTOMY, AN END TONE WAS HEARD, INDICATING A COMPLETED SEAL CYCLE, BUT NO TISSUE EFFECT WAS SEEN. WHEN TAKEN OUT OF THE PORT, A REGRASP ALARM SOUNDED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 191827

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK