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

Model Number	CH-S400-XZ-EA
Medical Device Problem Codes	Erratic or Intermittent Display (1182); No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the autoclavable camera head dull light source image flickering.During the initial evaluation of the returned device, no image was shown on the screen.There was no patient injury reported.
Additional Manufacturer Narrative
Date of event is unknown.Additional information will be provided if available.The final investigation has been completed.The failure reported by the customer and identified during the inspection have been not confirmed.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.Also, for the no image showing on screen due to faulty cable or connector.¿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: 50682288
• Report Number: 3002808148-2026-31554
• Device Sequence Number: 21430651
• Product Code: FET
• UDI-Device Identifier: 04953170375552
• UDI-Public: 04953170375552
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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