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

Model Number	CH-S190-XZ-E
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported problem with image during service maintenance involving an olympus camera head.Additionally, during the device analysis, intermittent image and failed leak test were observed.There was no patient injury reported.
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: intermittent image and failed leak test.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction problem with image was traced to 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: HD 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: 50307500
• Report Number: 3002808148-2026-28855
• Device Sequence Number: 10630145
• Product Code: FET
• UDI-Device Identifier: 04953170310799
• UDI-Public: 04953170310799
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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-S190-XZ-E
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2016
• 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