MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VIDEO ADAPTER; Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Model Number	AR-T12E
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction

• Brand Name: VIDEO ADAPTER
• Common Device Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
• 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 ; +1(508)207-7661
• MDR Report Key: 50177615
• Report Number: 3002808148-2026-27396
• Device Sequence Number: 15519586
• Product Code: FET
• UDI-Device Identifier: 04953170023804
• UDI-Public: 04953170023804
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K971416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

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: AR-T12E
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/30/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown