BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER TURBO VAC 90

    MDR report key: 3250738 · Received June 19, 2013

    Report

    Report Number
    3250738
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    ARTHROWAND WAS NOT WORKING DURING A LEFT KNEE ACL RECONSTRUCTION; HAD TO OPEN 3 WANDS PER MD; ALL THREE WASTED.======================MANUFACTURER RESPONSE FOR ARTHROWAND, ARTHROWAND (PER SITE REPORTER).======================REP ARRIVED TO EVALUATE EQUIPMENT AND INSERVICE STAFF OF PROPER USE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TO BE USED FOR ACL RECONSTRUCTION. OTHERWISE UNKNOWN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278495 SUPER TURBO VAC 90 ARTHROSCOPE GEI ARTHROCARE CORP. ASH 4250-01 1033208/1033213/1034159
    278496 * * GEI * * *
    278497 * * GEI * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *