BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC

    MDR report key: 746707 · Received September 6, 2005

    Report

    Report Number
    MW1036530
    Event Type
    Other
    Date Received
    September 6, 2005
    Date of Event
    September 2, 2005
    Report Date
    September 6, 2005
    Manufacturer
    MEDTRONIC
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TUNA MACHINE WAS NOT OPERATING PROPERLY WHILE PREPPING PT FOR PROCEDURE. PRODUCT REP WAS IN THE OR AS WELL. REP WAS UNABLE TO FIX MACHINE. CASE WAS CANCELLED AND MACHINE TAKEN OUT OF SERVICE. REP TOOK DEVICE WITH HIM. NEW, FUNCTIONAL MACHINE WAS BROUGHT IN FOR RESCHEDULED CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC TRANSURETHRAL NEEDLE ABLADER -TUNA- KNS MEDTRONIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other