BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEECLEAR XCL

    MDR report key: 3605284 · Received January 22, 2014

    Report

    Report Number
    3605284
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 22, 2014
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    FCZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SEECLEAR SMOKE EVACUATOR WOULD NOT EVACUATE SMOKE PROPERLY DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51863 SEECLEAR XCL TUBE, SMOKE REMOVAL, ENDOSCOPIC FCZ COOPERSURGICAL, INC. * 147343

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR OTHER