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

Model Number	ENF-VH2
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus was informed that during an onsite visit, the user facility staff was experiencing fluid corrosion and leak testing was not being conducted correctly.The user facility was provided reprocessing in-service and review of their leakage tester/leakage testing practices was completed.No patient infections or injuries reported.
Additional Manufacturer Narrative
No device was returned to olympus for evaluation.However, as part of the investigation into this report, an olympus endoscopy support specialist (ess) was dispatched on-site to assess the reprocessing practices at the user facility.Based on the observation summary report from ess, there were some reprocessing deviations observed during the on-site visit, and they are as follows: facility was not following ifus (instructions for use) for leak testing, facility was submerging the scope in clean water and then connecting it to the leak tester and once the leak test was completed then they were only removing the venting port and keeping the rest of the scope submerged in water.Facility was also storing the scopes with the eto (ethylene oxide (gas) valve) cap on the scope.The customer was asked if the scope was being put into water with the eto cap on.The customer noted that they only keep the cap on so they will know what scope is what.Ess explained to customer that if that scope is submerged in the water with the cap on then the scope will be flooded with fluid.During the in-service it was also noted that once facility has completed leak test, they are putting the scope in hld and not doing the manual cleaning in the detergent.Facility did not have any detergent in the department at the time.Ess went over the ifus with customer and explained that if they were not doing the manual cleaning and getting the debris off the scope then the scope could possibly have debris left and that area wasn¿t being in contact in the hld.The facility noted that they would be pausing all cases until they had the detergent on hand and all the staff has been trained on reprocessing the scope.Ess performed a scope reprocessing and infection control in-service for the staff.Covered infection control information referenced in the user manual and reprocessing manual.All products were listed in the product section of the request.All attendees were listed on the attendance sheet of the on-track reprocessing form and the customer was emailed a copy of the forms.Customer uses an automatic endoscope reprocessor (aer) to reprocess their scopes.Ess recommended that the customer contact the manufacturer of that equipment for proper use.The ess provided the user facility staff reprocessing training materials for their reference.
Event or Problem Description
No new information has been provided by the customer.
Additional Manufacturer Narrative
Updated: b5, h2, h3, h4, h6, h11.This report is being supplemented to provide additional information based on the approved final investigation.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.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: 21692828
• Report Number: 3002808148-2025-05063
• Device Sequence Number: 21187006
• Product Code: EOB
• UDI-Device Identifier: 04953170411427
• UDI-Public: 04953170411427
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182102
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: ENF-VH2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2023
• 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