BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 2241571 · Received September 2, 2011

    Report

    Report Number
    1717344-2011-00786
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 22, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT 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 A PIECE OF THE BLUE INSULATION CAME OFF OF THE DEVICE AND FELL INTO THE PATIENT CAVITY. THE PIECE WAS RETRIEVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO PATIENT 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) 210952X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK