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

Model Number	CH-S400-XZ-EA
Medical Device Problem Codes	Break (1069); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported bad image and defect in the glass involving an olympus autoclavable camera head.There were no reports of patient harm.
Event or Problem Description
During the initial evaluation of the device it was observed, failed leak test between cos ring and rear cover.
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.
Additional Manufacturer Narrative
This supplemental report is being submitted because the final investigation has been completed.Updated field: d9, g3, g6, h2, h3, h6 and h11.Date of event is unknown.Additional information will be provided once available.The final investigation has been completed.The product was returned to olympus and the reported failures by the customer were not confirmed, however the issue identified during inspection, was confirmed.A definitive root cause could not be identified.Based on the investigation results, the most probable cause of the reported issues could not be established.Regarding the malfunction failed leak test between cos ring and rear cover the cause was traced to component failure.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 AUTOCLAVABLE 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: 50751809
• Report Number: 3002808148-2026-32091
• Device Sequence Number: 10309299
• Product Code: FET
• UDI-Device Identifier: 04953170375552
• UDI-Public: 04953170375552
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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-EA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2019
• 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