BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUVIEW XE LAPAROSCOPIC SMOKE ELIMINATION

    MDR report key: 9972000 · Received April 16, 2020

    Report

    Report Number
    MW5094181
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Date of Event
    April 14, 2020
    Report Date
    April 15, 2020
    Manufacturer
    LEXION MEDICAL LLC
    Product Code
    FCZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TUBING FROM LEXION MEDICAL PNEUVIEW XE BECAME SEPARATED AT THE MOLDED, WHITE COUPLER DURING THE CASE. FDA SAFETY REPORT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434165 PNEUVIEW XE LAPAROSCOPIC SMOKE ELIMINATION TUBE, SMOKE REMOVAL, ENDOSCOPIC FCZ LEXION MEDICAL LLC 9660-XE 082080001

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR