BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA PLUME AWAY 6.0

    MDR report key: 8180620 · Received December 18, 2018

    Report

    Report Number
    MW5082278
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    December 17, 2018
    Report Date
    December 17, 2018
    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

    COOPER SURGICAL INC., ULTRA PLUME AWAY 6.0 WAS RECEIVED IN THE STERILE PACKAGING WITH THE SUCTION TUBING BENT OVER THE TUBING CONNECTOR TO THE POINT WHERE THE MEMORY OF THE TUBING COULD NOT BE CORRECTED, AND THE DEVICE COULD NOT BE UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012041 ULTRA PLUME AWAY 6.0 LAPAROSCOPIC SMOKE EVACUATOR FCZ COOPER SURGICAL, INC. 0620-030-606 256710

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR