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

Model Number	CH-S700-XZ-EA
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the autoclavable camera head, which is an olympus asset with no reported complaint.During the evaluation of the device, failed water leak test on cable was observed.The service repair technician indicated that the most likely cause was failed water leak test due to cut on cable. there was no patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.Based on the results of the investigation, the most probable cause of this complaint is expected or random component failure without any design or manufacturing issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: 4K CAMERA HEAD
• Common Device Name: AUTOCLAVABLE 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: 50274575
• Report Number: 3002808148-2026-28501
• Device Sequence Number: 10578501
• Product Code: FET
• UDI-Device Identifier: 04953170430268
• UDI-Public: 04953170430268
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K251336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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: Other
• Device Model Number: CH-S700-XZ-EA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2025
• 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