BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATED HUMIDIFIED SMOKE EVACUATION TUBE SET

    MDR report key: 21992773 · Received May 9, 2025

    Report

    Report Number
    21992773
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    October 24, 2024
    Report Date
    May 1, 2025
    Manufacturer
    W.O.M. WORLD OF MEDICINE GMBH
    Product Code
    OSV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LUER LOCK OF PNEUMOCLEAR HEATED HUMIDIFIED SMOKE EVALUATION TUBE SET KEPT FALLING OFF (REF #0620050350, LOT #K24D068). MANUFACTURER RESPONSE FOR LAPAROSCOPIC DISPOSABLE SUPPLY, PNEUMOCLEAR HEATED HUMIDIFIED SMOKE EVALUATION SET (PERT SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946627 HEATED HUMIDIFIED SMOKE EVACUATION TUBE SET INSUFFLATOR, ENDOSCOPIC VESSEL HARVESTING OSV W.O.M. WORLD OF MEDICINE GMBH 0620050350 K24D068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown