BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAZZ SUCTION VALVE

    MDR report key: 21901627 · Received April 24, 2025

    Report

    Report Number
    1000513161-2025-00012
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    October 4, 2021
    Report Date
    April 24, 2025
    Manufacturer
    FUJIFILM MEDWORK GMBH
    Product Code
    ODC
    UDI-DI
    04044503035158
    Product Problem
    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 #3020707080-2025-00002. REF FFMW COMP #(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-F1-100 FROM THE MANUFACTURER. DURING AN FDA-INSPECTION ON (B)(6) 2025, IT WAS FOUND THAT COMPLAINT INVOLVING THE VAL1-F1-100 WAS NOT EVALUATED FOR REPORTABILITY TO THE FDA. THEREFORE, VAL1-F1-100 COMPLAINT RECEIVED PRIOR TO THE INSPECTION WERE EVALUATED FOR FDA MDR. FUJIFILM MEDWORK GMBH RECEIVED THIS COMPLAINT ON (B)(6) 2025, DETERMINED IT TO BE REPORTABLE (MDR 3020707080-2025-00002 SUBMITTED ON APRIL 16TH, 2025). DURING A COLONOSCOPY THERAPY, USING A PENTAX ENDOSCOPE AND FUJIFILM VAL1-F1-100 VALVE, THE MEMBRASE HAS NOT OPENED DURING THE INTRODUCTION OF A SYRINGE, AND THE INTRODUCTION OF THE ENDOSCOPY IS SOMETIMES REALLY DIFFICULT. IT CREATED A SITUATION OF POTENTIAL SPATTERING SINCE IT DEMANDS TO OPEN THE CORK OF THE VALVE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476635 JAZZ SUCTION VALVE ENDOSCOPE CHANNEL ACCESSORY ODC FUJIFILM MEDWORK GMBH VAL1-F1-100 22153125 04044503035158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown