MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ENDOSCOPE MODEL EC-600LS; COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	EC-600LS
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inspection of the scope revealed no damage or foreign matter attachment that could lead to contamination.Since the culture test after re-reprocessing the scope showed negative results, it is possible that there was a deficiency in the facility's reprocessing procedure.However, this could not be identified.No health damages related to this issue have occurred.This mdr was submitted in an abundance of caution.
Event or Problem Description
It was reported that the scope was swabbed for standard micro testing on 10/28/2025.Culture returned positive 10/31/2025.Scope was reprocessed using aer on 10/31/2025 and removed from service.The scope was culture tested as part of their monthly testing stance, and it failed.They put it in the aer again and culture tested again, this time it passed.The scope was sent in for evaluation.The area that failed the initial test was the distal tip.The facility staff (registered nurse) confirmed the scope in question was last used on a patient (b)(6) 2025.No malfunction occurred when the scope in question was used on a patient.The scope was culture tested on 9/30/2025 and the results were negative.The scope was swabbed for standard micro testing on 10/28/2025.Culture returned positive 10/31/2025.The scope was re-cultured on 10/31/2025 and 11/3/2025 with negative results.After the scope was manually cleaned through their aer unit and placed in storage, there were no issues found after the cleaning process.Customer has not confirmed the positive culture organism.
Additional Manufacturer Narrative
Added the information to the section h 4.Device manufacture date.

• Brand Name: FUJIFILM ENDOSCOPE MODEL EC-600LS
• Common Device Name: COLONOSCOPE 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: 23891915
• Report Number: 3001722928-2025-00034
• Device Sequence Number: 17281342
• Product Code: FDF
• UDI-Device Identifier: 04547410330229
• UDI-Public: (01)04547410330229(11)170301
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162622
• 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
• Report Date (Section B): 01/05/2026

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-600LS
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/25/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2017
• 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