MAUDE Adverse Event Report: FUJIFILM MEDWORK GMBH JAZZ SUCTION VALVE; 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
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.
Additional Manufacturer Narrative
Ref comp #(b)(4).Ref medwatch report #3020707080-2025-00002.Ref ffmw comp #(b)(4).

• 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: 21901627
• Report Number: 1000513161-2025-00012
• Device Sequence Number: 14455255
• Product Code: ODC
• UDI-Device Identifier: 04044503035158
• UDI-Public: 04044503035158
• 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): 04/24/2025
• 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: 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
• 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: 04/24/2025
• 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