MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. 12G-SDI CABLE 8.5M

Model Number	MAJ-2429
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the serial digital interface cable caused image noise.The issue was found during a therapeutic video-assisted thoracoscopic surgery, and it was completed with the same device.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information and the results of the final investigation.Updated fields: b5, d8, h2, h3, h6, h11 the device was returned to olympus for inspection, and the reported failure was confirmed.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: the most probable cause of reported issue was traced to a component failure.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the serial digital interface cable exhibited green noise with horizontal stripes and flickering.

• Brand Name: 12G-SDI CABLE 8.5M
• Common Device Name: SDI CABLE
• 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: 24271899
• Report Number: 3002808148-2026-03416
• Device Sequence Number: 16116781
• Product Code: FET
• UDI-Device Identifier: 04953170415630
• UDI-Public: 04953170415630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K222861
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: MAJ-2429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 05/04/2026
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LMD-XH320ST.; OTV-S700.
• Patient Sex: Unknown