MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. 4K CAMERA HEAD; Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Model Number	CH-S400-XZ-EB
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Loose or Intermittent Connection (1371); Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the camera head did not stay locked in the tower during reprocessing.During the initial evaluation of the device, error e224, bad cable or connector, and water leakage were observed.There was no patient involvement.
Additional Manufacturer Narrative
The investigation is still ongoing.A supplemental report will be submitted when the investigation has been completed or when new and significant information becomes available.Olympus will continue to monitor the field performance of this device.

• Brand Name: 4K CAMERA HEAD
• 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: 50345141
• Report Number: 3002808148-2026-29156
• Device Sequence Number: 17652114
• Product Code: FET
• UDI-Device Identifier: 04953170374609
• UDI-Public: 04953170374609
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172817
• 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,Followup
• Report Date (Section B): 08/25/2026

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: CH-S400-XZ-EB
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2019
• 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