BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 3880644 · Received May 28, 2014

    Report

    Report Number
    1717344-2014-00454
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 8, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT OOZING OCCURRED DURING A LAPAROSCOPIC COLECTOMY ALTHOUGH END TONES, INDICATING A COMPLETED SEAL CYCLE, WERE HEARD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313556 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 249390X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK