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

Model Number	CV-1500
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the endoscopic image blacked out during a diagnostic colonoscopy procedure while the patient was under sedation and the device was inside the patient involving an olympus video system center.The customer contacted olympus technical assistance center (tac) by phone and reported a problem with the image.No troubleshooting was performed, as the customer indicated that tac support was contacted in error and requested repair processing only.The device will be returned to olympus for evaluation.There was no patient injury reported.
Additional Manufacturer Narrative
The device was returned to olympus for inspection, and the reported failure was not confirmed.Based on the results of the investigation, a probable root cause could not be identified.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: 50221383
• Report Number: 3002808148-2026-28001
• Device Sequence Number: 18719418
• Product Code: FET
• UDI-Device Identifier: 04953170414596
• UDI-Public: 04953170414596
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/12/2026

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?: Yes
• Date Returned to Manufacturer: 07/24/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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