BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3810466 · Received April 15, 2014

    Report

    Report Number
    1717344-2014-00278
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 25, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A J-POUCH/LARGE BOWEL RESECTION PROCEDURE, AFTER SEALING SEVERAL TIMES, THE DEVICE WOULD NOT LONGER SEAL COMPLETELY DESPITE MULTIPLE ATTEMPTS. MONITOR OOZING/BLEEDING OCCURRED. REPORTEDLY, NO REGRASP ALARMS SOUNDED AND ENDTONES, INDICATING COMPLETED SEAL CYCLES, WERE HEAD. ANOTHER DEVICE WAS OPENED AND USED TO CONTINUE THE PROCEDURE. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230893 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK