MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA XENON LIGHT SOURCE

Model Number	CLV-S45
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated, and the evaluation found the power switch didn't work occasionally due to faulty main board.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
It was reported that during maintenance found lamplighters of xenon light source did not light up, and panel buttons sometimes did not work.There was no procedure involved.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over eight (8) years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the power switch stopped working due to a faulty main board.Additionally, the customer¿s complaint that the panel buttons sometimes did not work was not reproduced, and the root cause could not be identified.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus patient was not under anesthesia and no delay.

• Brand Name: VISERA 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: 18592359
• Report Number: 3002808148-2024-00826
• Device Sequence Number: 6595390
• Product Code: NWB
• UDI-Device Identifier: 04953170275777
• UDI-Public: 04953170275777
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2024

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-S45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 02/04/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2015
• 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