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

Model Number	CH-S700-XZ-EA
Medical Device Problem Codes	Poor Quality Image (1408); 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 reported poor image quality during inspection for use involving an olympus autoclavable camera head.During the initial evaluation of the returned device, a failed leak test was observed.There was no patient involvement.
Additional Manufacturer Narrative
The date of event is unknown.Additional information will be provided if available.The final investigation was completed.The failure reported by the customer was not confirmed, however, the failures identified during the initial evaluation was confirmed.A definitive root cause could not be identified.However, based on the results of the investigation, the most probable cause of the reported malfunction could not be determined.In addition, the cause of the failed leak test 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 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: 50917289
• Report Number: 3002808148-2026-33996
• Device Sequence Number: 5344913
• Product Code: FET
• UDI-Device Identifier: 04953170430268
• UDI-Public: 04953170430268
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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-S700-XZ-EA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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