MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. LIGHT SOURCE CABLE WITH REMOTE 10 M

Model Number	MAJ-1913
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted, when the investigation is completed or if additional information becomes available.E2/e3: no information available for the occupation of the initial reporter or whether they are a healthcare professional.Three attempts were performed to obtain additional information, but no response was received from the customer.
Event or Problem Description
It was reported, the light source cable with remote 10 m, when combined with a video system center.A light source and additional light source cable had color bars appeared on the monitor and then no image.And the monitor displayed b30 error code.This was found, during maintenance.There were no reports of patient involvement.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a definitive root cause could not be determined.The customer reported b30 error which is a communication error on the device.The root cause could be due a defective cable, a connection problem with the cable.Olympus will continue to monitor field performance for this device.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: LIGHT SOURCE CABLE WITH REMOTE 10 M
• Common Device Name: LIGHT SOURCE 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: 20777155
• Report Number: 3002808148-2024-37987
• Device Sequence Number: 4361782
• Product Code: NWB
• UDI-Device Identifier: 04953170304873
• UDI-Public: 04953170304873
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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-1913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLV-S190, SN#: (B)(6); MAJ-1959; OTV-S190, SN#: (B)(6)
• Patient Sex: Unknown