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

Model Number	CH-S190-XZ-Q
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was visually inspected, and functional testing was performed.Based on functional testing performed, the device failed the standard specification.Device history record (dhr) review: a dhr was reviewed and no issues that could have caused or contributed to the reported issue were found.Instructions for use (ifu): in the instruction manual, the following statement is found under "warning" in the section "inspection of remote switch, focus and zoom switch".The following is a warning in the instruction manual "checking remote switches, focus and zoom switches": "always check that all remote switches are working properly before using the remote switches, even if you do not plan to use them.Failure to unfreeze the image during use may result in injury to the body cavity, bleeding, or perforation.Always confirm that all focus and zoom switches are working properly before use, even if you do not plan to use the focus and zoom switches.Failure to do so may cause the switches to malfunction during use, which may result in injury to the body cavity, bleeding, or perforation.The following is described in the instruction manual "preparation and inspection_inspection of the mela head".Check that there is no loosening or rattling of the free lock lever when the free lock lever is lightly held and lightly rotated counterclockwise.Check that there is no looseness or rattling in the scope mount when the scope mount is operated.The most probable cause of the complaint is cause traced to component failure.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was observed that during the device evaluation, the camera head exhibited flooding in the main unit imaging and water immersion in the camera cable.There were no reports of patient involvement.

• 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 ; 5082077661
• MDR Report Key: 18764580
• Report Number: 3002808148-2024-30936
• Device Sequence Number: 4500104
• Product Code: FET
• UDI-Device Identifier: 04953170310782
• UDI-Public: 04953170310782
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2024

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-Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown