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

Model Number	CLV-S45
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when power was turned on, a creaking sound was heard, and the emergency light came on immediately at the light source.There were no reports of patient harm.Additional information on the event has been requested.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
The issue occurred during preparation for use for a diagnostic procedure that was completed with the same device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the device evaluation and legal manufacturer's final investigation.   new information added on fields: b3, b5, d8, h3, h4 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured. the device was returned to olympus for inspection, and the customer's malfunction was confirmed. based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the cause was the faulty heat sink assembly.It improved after the lamp was replaced with the entire heat sink.Olympus will continue to monitor field performance for this device. .

• 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: 19140852
• Report Number: 3002808148-2024-03645
• Device Sequence Number: 17993601
• Product Code: NWB
• UDI-Device Identifier: 04953170275753
• UDI-Public: 04953170275753
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: 04/11/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2014
• 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