BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAZZ SUCTION VALVE

    MDR report key: 21885757 · Received April 22, 2025

    Report

    Report Number
    1000513161-2025-00013
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    May 1, 2022
    Report Date
    April 22, 2025
    Manufacturer
    FUJIFILM MEDWORK GMBH
    Product Code
    ODC
    UDI-DI
    04044503055828
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REF MEDWATCH REPORT #3020707080-2025-00004. (B)(4).

    Description of Event or Problem · 0

    ON APRIL 15TH, 2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED BY FUJIFILM MEDWORK GMBH OF THE REPORTABLE EVENT INVOLVING VAL1-G7-50 FROM THE MANUFACTURER. DURING AN FDA-INSPECTION ON MARCH 25TH, 2025, IT WAS FOUND THAT COMPLAINT INVOLVING THE VAL1-G7-50 WAS NOT EVALUATED FOR REPORTABILITY TO THE FDA. THEREFORE, VAL1-G7-50 COMPLAINT RECEIVED PRIOR TO THE INSPECTION WAS EVALUATED FOR FDA MDR. FUJIFILM MEDWORK GMBH RECEIVED THIS COMPLAINT ON JUNE 22ND, 2022, AND ON MARCH 27TH, 2025, DETERMINED IT TO BE REPORTABLE (MDR 3020707080-2025-00004 SUBMITTED ON APRIL 16TH, 2025). DURING A COLONOSCOPY THERAPY AND GASTROSCOPY DIAGNOSIS PROCEDURE, USING A FUJIFILM ENDOSCOPE, THE FUJIFILM VAL1-G7-50 VALVE WAS FOUND TO BE LEAKING. THE LEAKING BIOPSY VALVE MADE IT DIFFICULT TO ENTER INSTRUMENTS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258088 JAZZ SUCTION VALVE ENDOSCOPE CHANNEL ACCESSORY ODC FUJIFILM MEDWORK GMBH VAL1-G7-50 22250071 04044503055828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown