BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAJET II

    MDR report key: 3052038 · Received April 1, 2013

    Report

    Report Number
    3052038
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 1, 2013
    Manufacturer
    SMITH & NEPHEW
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    VERSAJET QUIT WORKING HALF WAY THROUGH THE CASE. THE DEVICE WOULD NOT ADVANCE WATER AND UNABLE TO PRIME THE AIR OUT OF THE LINE. PERFORMED TROUBLESHOOTING TECHNIQUES IN GUIDE BOOK. A NEW HAND PIECE WAS OPENED TO COMPLETE THE PROCEDURE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HYDROSURGICAL ABLATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131413 VERSAJET II LAVAGE, JET FQH SMITH & NEPHEW 66800041 50430031

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR