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

Model Number	MAJ-1933
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event was conservatively classified as a serious injury due to the procedure allegedly being prolonged by 30 or more minutes.This report is related to 071916.This report has been submitted by the importer under this mdr report number 2429304-2025-00050.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 that during a diagnostic colonoscopy under sedation, the digital light source cable in use with a video processor experienced a b30 error.This resulted in a procedural delay of greater than 30 minutes.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report has been submitted by the importer under this mdr report number 2429304-2025-00050-01 this supplemental report is being submitted to provide additional information from the customer and the results of the complaint investigation.Updated fields: b5, h2 and h6.Corrections to b1, b2, and h1.This event was initially conservatively reported as a serious injury; however, upon further follow-up, the customer confirmed that the patient did not suffer any serious injury or adverse effects from the prolonged procedure, thus correcting b1, b2, and h1.B1 should not be marked as an adverse event, and b2 should not be marked at all.H1 should also not be marked.The h6 medical device problem reported would not be likely to cause or contribute to a death or a serious injury if it were to recur.The device was not returned to olympus.The customer's complaint was confirmed based on the remote service inspection conducted by the technical assistance center (tac), however, a conclusive finding cannot be confirmed.Based on the investigation, the definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information was received from the customer that the procedure was postponed 35 minutes, prior to the patient being sedated.There were no reports of patient harm.

• Brand Name: DIGTAL LIGHT SOURCE CABLE
• Common Device Name: DIGITAL 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: 21274108
• Report Number: 3002808148-2025-01589
• Device Sequence Number: 15471657
• Product Code: FDF
• UDI-Device Identifier: 04953170304972
• UDI-Public: 04953170304972
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K131780
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MAJ-1933
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 05/06/2025
• 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-190
• Patient Sex: Unknown