BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 1942286 · Received December 22, 2010

    Report

    Report Number
    1717344-2010-00997
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 29, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(4) 2010. THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE IS NOT AVAILABLE FOR EVAL. IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN ADRENALECTOMY, THE DEVICE ACTIVATED ALTHOUGH THE ACTIVATION BUTTON WAS NOT PUSHED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO TISSUE DAMAGE AND NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 192282

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK