BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA PLUME-AWAY 6.0 SMOKE EVACUATION SYSTEM

    MDR report key: 9596243 · Received January 15, 2020

    Report

    Report Number
    MW5092298
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    January 10, 2020
    Report Date
    January 13, 2020
    Manufacturer
    COOPER SURGICAL, INC.
    Product Code
    FCZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRODUCT LABELING ON THE COOPER SURGICAL, ULTRA PLUME-AWAY 6.0, SMOKE EVACUATION SYSTEM HAD BEEN NOTED TO BE DISCOLORED (YELLOWISH COLOR TO PORTION OF LABEL) UPON ITS ARRIVAL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57006 ULTRA PLUME-AWAY 6.0 SMOKE EVACUATION SYSTEM TUBE, SMOKE REMOVAL, ENDOSCOPIC FCZ COOPER SURGICAL, INC. 0620-030-606 269501
    57007 ULTRA PLUME-AWAY 6.0 SMOKE EVACUATION SYSTEM TUBE, SMOKE REMOVAL, ENDOSCOPIC FCZ COOPER SURGICAL, INC. 0620-030-606 269767

    Patients

    Seq Age Sex Outcome Treatment
    1