MAUDE Adverse Event Report: FUJIFILM MEDWORK GMBH JAZZ SUCTION VALVE; 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	05/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Ref medwatch report #3020707080-2025-00004.(b)(4).
Event or Problem Description
On april 15th, 2025, fujifilm healthcare americas corporation was informed by fujifilm medwork gmbh of the reportable event involving val1-g7-50 from the manufacturer.During an fda-inspection on march 25th, 2025, it was found that complaint involving the val1-g7-50 was not evaluated for reportability to the fda.Therefore, val1-g7-50 complaint received prior to the inspection was evaluated for fda mdr.Fujifilm medwork gmbh received this complaint on june 22nd, 2022, and on march 27th, 2025, determined it to be reportable (mdr 3020707080-2025-00004 submitted on april 16th, 2025).During a colonoscopy therapy and gastroscopy diagnosis procedure, using a fujifilm endoscope, the fujifilm val1-g7-50 valve was found to be leaking.The leaking biopsy valve made it difficult to enter instruments.No patient injury was reported.

• Brand Name: JAZZ SUCTION VALVE
• Common Device Name: ENDOSCOPE CHANNEL ACCESSORY
• Manufacturer (Section D): FUJIFILM MEDWORK GMBH; medworkring 1; höchstadt a.d. aisch, bavaria 91315 ; GM 91315
• MDR Report Key: 21885757
• Report Number: 1000513161-2025-00013
• Device Sequence Number: 18167243
• Product Code: ODC
• UDI-Device Identifier: 04044503055828
• UDI-Public: 04044503055828
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2025
• Report Date (Section F): 04/16/2025

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/15/2025
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/16/2025