MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS X1 VIDEO SYSTEM CENTER

Model Number	CV-1500
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the air supply automatically turned on when a scope was connected during inspection for use, involving an olympus video system center.There was no patient involvement.
Additional Manufacturer Narrative
The final investigation has been completed.The device was not returned to olympus for inspection, and the reported failure was not confirmed.The customer contacted olympus technical assistance center (tac) via phone.Tac documented that a cv-1500 reportedly had the free-air/air supply function turn on automatically when an endoscope was connected.An insufflator was confirmed to be connected to the cv-1500.Tac recommended confirming that users were properly connecting and disconnecting the scopes.Troubleshooting was not able to resolve the reported issue.The device will not be returned to olympus for evaluation.A root cause could not be identified.Based on the results of the investigation, it is likely the cause could not be established for the malfunction.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS X1 VIDEO SYSTEM CENTER
• Common Device Name: VIDEO SYSTEM CENTER
• 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: 50941828
• Report Number: 3002808148-2026-34287
• Device Sequence Number: 10722596
• Product Code: FET
• UDI-Device Identifier: 04953170414596
• UDI-Public: 04953170414596
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K222861
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: CV-1500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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