MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II XENON LIGHT SOURCE

Model Number	CLV-180
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the front panel of the subject device had a lighting failure.The issue occurred during an unspecified procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Correction: b5, d5 additional information: h3, h4, h6, h11 the device was returned to olympus for inspection, and the reportable malfunction was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the front panel and emergency lamp were blinking and the buttons were unresponsive.This is likely due to a turret unit failure.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Correction to b5 of the initial report.It was unknown when the event occurred.

• Brand Name: EVIS EXERA II XENON LIGHT SOURCE
• Common Device Name: XENON LIGHT SOURCE
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20757075
• Report Number: 3002808148-2024-11103
• Device Sequence Number: 8587735
• Product Code: NWB
• UDI-Device Identifier: 04953170216961
• UDI-Public: 04953170216961
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K133538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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: CLV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2009
• 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