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

Model Number	CH-S190-XZ-Q
Medical Device Problem Codes	Disconnection (1171); Leak/Splash (1354); Poor Quality Image (1408); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The end user facility contacted olympus to report when they tried to attach the scope to the hd autoclavable camera head, the camera head spins freely.There was no resistance, something was wrong with the coupler no patient or user harm has been reported.No procedural delays have been reported.
Additional Manufacturer Narrative
The subject device has been returned to an olympus repair center for evaluation and inspection, and the customer's reported problem has been confirmed.The coupler was spinning around freely due to a missing o-ring.The following additional findings were also identified during device evaluation: the connector tip was "smashed," there was noise on the image due to a faulty charged coupled device (ccd) and the leak test was failed due to a puncture on switch button three (3).A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the most probable cause of the malfunction reported by the customer was component failure, which is expected or random component failure without any design or manufacturing issue.Noting that it has been five years since this device's last preventative maintenance or repair, it's likely the user request occurred as a result of wear and tear.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.If additional information becomes available at a later date, this report will be supplemented.

• 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 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18458506
• Report Number: 3002808148-2024-30035
• Device Sequence Number: 3100478
• Product Code: FET
• UDI-Device Identifier: 04953170310782
• UDI-Public: 04953170310782
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2024

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: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2013
• 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