MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ENDOSCOPE MODEL EC-760R-V/L; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	EC-760R-V/L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the black stuff was coming out of the scope after the procedure.At the end of the case, the tech of the facility said the scope made a "weird" noise when flushing the scope.It was then taken to the scope cleaning room and during the brushing of the suction chamber, small black particles came out of the scope.They felt like hard plastic pieces of what the scope is made out of.
Additional Manufacturer Narrative
Supplemental mdr will be submitted when the additional investigation is completed.
Additional Manufacturer Narrative
Section d1 brand name is corrected.
Additional Manufacturer Narrative
No malfunctions were found as a result of inspecting the subject endoscope.Fujifilm conducted a component analysis of the small black particles came out of the endoscope channel.The results revealed that they were organic matter derived from the human body.Although it is highly likely that these particles originated from the patient who underwent the procedure using the endoscope, it was not possible to determine from when they existed the endoscope channel.No reports of health effects related to this issue have been received.

• Brand Name: FUJIFILM ENDOSCOPE MODEL EC-760R-V/L
• Common Device Name: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer (Section G): FUJIFILM HEALTHCARE MANUFACTURING SANO OFFICE; 700 konaka-cho; sano city, tochigi 327-0 001; JA 327-0001
• Manufacturer Contact: 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538
• MDR Report Key: 21888060
• Report Number: 3001722928-2025-00014
• Device Sequence Number: 11645350
• Product Code: FDS
• UDI-Device Identifier: 04547410358681
• UDI-Public: (01)04547410358681(11)230801
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2025

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 Model Number: EC-760R-V/L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/13/2025; 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown