MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VIDEO ADAPTER

Model Number	AR-T10E
Medical Device Problem Codes	Break (1069); Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, the video adapter exhibited corrosion on the e-coupler unit, rear frame unit, and on the rotating unit.Additionally, the eyepiece holder component was found broken.There was no patient involvement.
Additional Manufacturer Narrative
The returned device was visually inspected and functional testing was performed.The eyepiece holder/stopper was found broken.Additionally, the device evaluation identified corrosion in the e-coupler unit, rear frame unit and on the rotating unit.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the investigation, no nonconformances were found.A definitive root cause of the problem could not be identified based on the results of the investigation.A potential cause can be traced to component failure.To mitigate damage to the device, the instructions for use provides the following: mounting and dismounting of the scope: when loosening the scope lock, be careful not to turn it too strongly in the loosening direction.There is a possibility that the scope lock may be damaged.Application and conditions for cleaning, disinfection, and sterilization: drain thoroughly after immersion.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEO ADAPTER
• Common Device Name: VIDEO ADAPTER
• 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: 18861443
• Report Number: 3002808148-2024-31265
• Device Sequence Number: 3325401
• Product Code: GCJ
• UDI-Device Identifier: 04953170023729
• UDI-Public: 04953170023729
• Combination Product (Y/N): N
• PMA/510(K) Number: K955404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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: Other
• Device Expiration Date: 02/28/2024
• Device Model Number: AR-T10E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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