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

Model Number	VAL1-F1-100
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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).

• Brand Name: FROG
• 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: 21852964
• Report Number: 3020707080-2025-00002
• Device Sequence Number: 18133551
• Product Code: ODC
• UDI-Device Identifier: 04044503035158
• UDI-Public: 04044503035158
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K221264
• 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: 06/01/2023
• Device Model Number: VAL1-F1-100
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 22153125
• 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: 10/14/2021
• 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: 06/01/2021
• 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