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

Model Number	ENF-V2
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury

• Brand Name: VISERA 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
• MDR Report Key: 50740516
• Report Number: 2429304-2026-00122
• Device Sequence Number: 10367240
• Product Code: EOB
• UDI-Device Identifier: 04953170411342
• UDI-Public: 04953170411342
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/11/2026
• Report Date (Section F): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ENF-V2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/13/2026
• Device Age: 17 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/11/2026