BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIVATOR ENDOGATOR IRRIGATION TUBING

    MDR report key: 22814833 · Received August 15, 2025

    Report

    Report Number
    MW5174603
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    August 1, 2025
    Report Date
    August 13, 2025
    Manufacturer
    MEDIVATOR, INC.
    Product Code
    OCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ENDOGATOR IRRIGATION TUBING HOOKED UP TO ENDOSCOPE AND NO WATER WOULD COME THROUGH. THIS WAS DISCOVERED PRIOR TO PATIENT INVOLVEMENT- NO PATIENT HARM. CHECKED ANOTHER ENDOGATOR IRRIGATION SET WITH THE SAME LOT NUMBER AND IT HAD THE SAME MALFUNCTION- DID NOT LET WATER THROUGH. LOT 1000281937, EXP- 04/17/2028. REF REPORT: MW5174602.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2788284 MEDIVATOR ENDOGATOR IRRIGATION TUBING ENDOSCOPIC IRRIGATION/SUCTION SYSTEM OCX MEDIVATOR, INC. 1000281937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown