MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. LIGHT SOURCE CABLE; LIGHTSOURCE CABLE

Model Number	MAJ-1941
Medical Device Problem Codes	No Display/Image (1183); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject device had incompatible scope (error code e315) displays and no scope image displays.The event had occurred during service / maintenance (not in a clinical setting).There were no reports of patient involvement.
Additional Manufacturer Narrative
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
No additional information received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: h2, h6, h11.Corrected fields: e1 - country.The device was not returned to olympus for inspection and the reported failure was not confirmed.The customer contacted olympus technical assistance support (tac) via phone.Tac reviewed prior related issues and advised swapping the maj-1933 and maj-1941 cables from another tower to isolate the cause, noting that the connector socket or light source ports on the loaner clv-190 could be defective.No further activity was reported.The customer informed tac of the event.The device will not be returned to olympus for evaluation.Three attempts were performed to obtain additional information, but no response was received from the customer.A root cause could not be identified.Based on the results of the investigation.The most probable cause of the complaint is not established.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: LIGHT SOURCE CABLE
• Common Device Name: LIGHTSOURCE 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: 23323960
• Report Number: 3002808148-2025-18319
• Device Sequence Number: 21492117
• Product Code: FET
• UDI-Device Identifier: 04953170304996
• UDI-Public: 04953170304996
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202646
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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-1941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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