MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. RHINO-LARYNGO VIDEOSCOPE

Model Number	ENF-V3
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the rhino-laryngo videoscope had oily residue.The issue was found during reprocessing.There was no patient involvement.
Event or Problem Description
It was reported that an oily, waxy residue was found on multiple olympus enf-v3/rhino-laryngo videoscope and enf-vh/rhino-laryngo videoscope following reprocessing in the medivator automated endoscope reprocess.Primarily those reprocessed on (b)(6) 2025.The facility noted that alcohol removed the residue completely, while endozyme only partially improved it.No procedure delays were reported.There was no report of patient harm associated with this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The product was not returned to olympus for inspection; however, olympus technical assistance center (tac) provided remote troubleshooting for the oily residue that was found on scope.Troubleshooting was able to resolve the reported allegation.Olympus endoscopy support specialist (ess) was notified and engaged with the facility via email and phone, requesting additional information including affected model and serial numbers, point-of-use cleaning practices, detergent usage, and lubricant use.The facility confirmed that intercept detergent wipes were being used for point-of-use cleaning.Nursing staff were individually interviewed and confirmed to be following proper pre-cleaning procedures in accordance with the information for use (ifu).Additionally, an onsite visit was conducted by ess on december 4, 2025.The facility review summary confirmed that all reprocessing steps observed were performed in alignment with the olympus ifu across all categories, including procedure room setup, transportation and storage, reprocessing, care and handling, and facility layout.It was further reported that a significant improvement in the residue issue following the visit.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: RHINO-LARYNGO VIDEOSCOPE
• Common Device Name: RHINO-LARYNGO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23920778
• Report Number: 3002808148-2025-26796
• Device Sequence Number: 21038863
• Product Code: EOB
• UDI-Device Identifier: 04953170310416
• UDI-Public: 04953170310416
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K221638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: ENF-V3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2016
• 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