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

Model Number	AR-T10E
Medical Device Problem Codes	Break (1069); Misfocusing (1401)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for a therapeutic procedure, the subject device cable was broken and the lens was blurred.There were no reports of patient harm.
Additional Manufacturer Narrative
The subject device was received and the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.This report is also being supplemented to inform correction in section d4 (serial number ) -correction- the serial number from the initial mdr submitted is being corrected.The serial number is unknown and the serial number (b)(6) is not the correct number but a placeholder number for service inspection.The lot number for this adapter was not provided.Device evaluation was performed.The customer's allegation was not confirmed.The device was tested and passed all functional tests.Based on the results of the investigation, a definitive root cause cannot be identified.The device history review (dhrs) for this product have not been reviewed.Due to no available lot number, on the adapter unit, the device dhrs could not be retrieved for review.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during preparation for a therapeutic procedure, the subject device cable was broken and the lens was blurred.There were no reports of patient harm.

• 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: 18853311
• Report Number: 3002808148-2024-31237
• Device Sequence Number: 7226891
• Product Code: GCJ
• UDI-Device Identifier: 04953170023729
• UDI-Public: 04953170023729
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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: AR-T10E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 03/10/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/09/2024
• 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