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

Model Number	CH-S700-XZ-EA
Medical Device Problem Codes	Degraded (1153); Communication or Transmission Problem (2896); Gas/Air Leak (2946); Optical Distortion (3000); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the camera head had distorted image.During the initial evaluation of the device, it was observed that smashed connector, failed leak test, image quality error (error e238) shown on monitor.No patient harm was reported.
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was not confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: smashed connector, failed leak test, image quality error (error e238) shown on monitor a definitive root cause could not be identified.Based on the results of the investigation, the most probable cause of the reported malfunction could not be determined.Additionally, the cause of the malfunction was traced to the component failure 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: 50273469
• Report Number: 3002808148-2026-28488
• Device Sequence Number: 13430779
• Product Code: FET
• UDI-Device Identifier: 04953170430268
• UDI-Public: 04953170430268
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Administrator/Supervisor
• 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: Health Professional
• Device Model Number: CH-S700-XZ-EA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown