BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAZZ SUCTION VALVE

    MDR report key: 21767154 · Received April 3, 2025

    Report

    Report Number
    1000513161-2025-00009
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    March 13, 2023
    Report Date
    April 3, 2025
    Manufacturer
    FUJIFILM MEDWORK GMBH
    Product Code
    ODC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REF COMP # (B)(4). REF MEDWATCH REPORT # 3020707080-2025-00001.

    Description of Event or Problem · 0

    FUJIFILM MEDWORK GMBH RECEIVED THE COMPLAINT ON MARCH 16TH, 2023, BUT IT WAS NEVER REPORTED TO THE FDA. THIS POTENTIALLY REPORTABLE EVENT WAS IDENTIFIED DURING AN FDA-INSPECTION ON MARCH 25TH, 2025, THEREAFTER THE MANUFACTURER REPORTED IT ON MARCH 27TH 2025, VIA MDR 3020707080-2025-00001. ON MARCH 27TH, 2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF THE REPORTABLE EVENT INVOLVING VAL1-G7-50 FROM THE MANUFACTURER. THE FROG VALVES, WHICH ARE PART OF THE VAL1-G7-50 SET, ARE EXPERIENCING LEAKAGE IN OVER 80% OF CASES AND EXHIBIT PUNCHING DEFECTS. RECENTLY, PARTS OF THE VALVE WERE FOUND IN THE PATIENT, POSING A SIGNIFICANT SAFETY RISK. ADDITIONALLY, DUE TO THE DEFECTS, FULL SUCTION CANNOT BE ACHIEVED, AND SEVERAL VALVES ARE DRIPPING DIRTY FLUID, RESULTING IN SUBSTANTIAL GAS LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445733 JAZZ SUCTION VALVE ENDOSCOPE CHANNEL ACCESSORY ODC FUJIFILM MEDWORK GMBH VAL1-G7-50 22350660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other