BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FROG

    MDR report key: 21852964 · Received April 17, 2025

    Report

    Report Number
    3020707080-2025-00002
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    October 4, 2021
    Report Date
    May 13, 2025
    Manufacturer
    FUJIFILM MEDWORK GMBH
    Product Code
    ODC
    UDI-DI
    04044503035158
    PMA / PMN Number
    K221264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE: REFERENCING MDR 1000513161-2025-00012 (SUBMITTED ON APRIL 24TH, 2025 ) IN BLOCK H10 IN SUPPLEMENTAL MANUFACTURER MDR 3020707080-2025-00002. REF INITIAL REPORT #3020707080-2022-00001. REF INITIAL MANUFACTURER MDR #3020707080-2025-00002. REF HCUS COMP (B)(4). REF FFMW COMP (B)(4).

    Additional Manufacturer Narrative · 0

    REF (B)(4). ON OCTOBER 14TH 2021, A COMPLAINT WAS RECEIVED, BUT IT WAS NEVER EVALUATED FOR REPORTABILITY TO THE FDA. THIS WAS IDENTIFIED DURING AN FDA-INSPECTION ON MARCH 25TH 2025, THEREFORE, FUJIFILM MEDWORK GMBH IS REPORTING IT NOW.

    Description of Event or Problem · 0

    THE MEMBRASE HAS NOT OPENED DURING THE INTRODUCTION OF A SYRINGE ET, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134881 FROG ENDOSCOPE CHANNEL ACCESSORY ODC FUJIFILM MEDWORK GMBH VAL1-F1-100 22153125 04044503035158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown