MAUDE Adverse Event Report: FUJIFILM MEDWORK GMBH JAZZ; ENDOSCOPE CHANNEL ACCESSORY

Model Number	VAL1-G7-50
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref hcus comp#: (b)(4).Ref ffmw comp#: (b)(4).On march 4th, 2022, 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.
Event or Problem Description
No products can be pushed through the opening without perforating the frog.This problem only occurred with the last batch that was delivered.
Additional Manufacturer Narrative
Update: referencing mdr 1000513161-2025-00014 (submitted on april 22nd, 2025) in block h10 in supplemental manufacturer mdr 3020707080-2025-00003.Ref initial report #3020707080-2022-00001, ref initial manufacturer mdr #3020707080-2025-00003, ref hcus comp # (b)(4), ref ffmw comp # (b)(4).

• Brand Name: JAZZ
• Common Device Name: ENDOSCOPE CHANNEL ACCESSORY
• Manufacturer (Section D): FUJIFILM MEDWORK GMBH; medworkring 1; höchstadt a.d. aisch, bavaria 91315 ; GM 91315
• Manufacturer (Section G): FUJIFILM MEDWORK GMBH; medworkring 1; höchstadt a.d. aisch, bavaria 91315 ; GM 91315
• Manufacturer Contact: dorian lutz ; medworkring 1; höchstadt a.d. aisch, bavaria 91315 ; GM 91315
• MDR Report Key: 21853135
• Report Number: 3020707080-2025-00003
• Device Sequence Number: 21037120
• Product Code: ODC
• UDI-Device Identifier: 04044503055828
• UDI-Public: 04044503055828
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K210625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2024
• Device Model Number: VAL1-G7-50
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 22250071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown