MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. 4K CAMERA HEAD

Model Number	CH-S400-XZ-EB
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the camera head for a separate issue.During the initial evaluation of the returned device, a loss of watertightness and the coupler was found to detach from the scope were observed.No patient involvement.
Additional Manufacturer Narrative
The final investigation has been completed.The failure identified during the inspection have been confirmed a definitive root cause could not be identified.Based on the results of the investigation, the most probable cause of the complaint is cause traced to component failure.For the coupler detaches from the scope due to deterioration of the coupler unit, water tightness is lost due to the focus ring was cracked.Olympus will continue to monitor the field performance of this device and evaluate any additional information received through post-market surveillance activities.

• Brand Name: 4K CAMERA HEAD
• Common Device Name: CAMERA HEAD
• 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: 50782601
• Report Number: 3002808148-2026-32458
• Device Sequence Number: 10516069
• Product Code: FET
• UDI-Device Identifier: 04953170374609
• UDI-Public: 04953170374609
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K172817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 09/02/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/16/2026
• 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