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

Model Number	CLV-S40PRO
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the customer have not returned the device for evaluation.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
The customer reported to olympus the visera pro xenon light source, when turning on the power to the device, when the light is turned on, the lamp is about 300 hours, but the emergency light is on.It was restored by restarting.The issue occurred during the preparation for use.The procedure was unknown and it was completed using the same set of equipment.There are no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation and the device evaluation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the subject device was manufactured.The device was returned, and an evaluation was completed for it.During inspection, the event was confirmed.Based on the results of the investigation, the root cause for the event could not be determined.However, it is likely that this event occurred due to the effects of long-term use, as a result of a combination of factors such as the inadvertent malfunction of the power supply unit that supplied power, the main board that controlled the lighting signal of lamp, and the igniter unit that ignited lamp, and the degradation of lamp.The following is included in the instructions for use: "when the package insert of clv-s40pro was checked, the following statements were checked.The service life of the products shall be six years after shipment (after delivery) (subject to self-certification (our data)).The duration of life is the number of years when proper use, such as performing a pre-use inspection as shown in the "package insert" or the "instructions for use", and performing repair or overhaul based on the results of the inspection, is performed." olympus will continue to monitor field performance for this device.

• Brand Name: VISERA PRO 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: 18344432
• Report Number: 3002808148-2023-14378
• Device Sequence Number: 17709495
• Product Code: GCT
• UDI-Device Identifier: 04953170228933
• UDI-Public: 04953170228933
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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-S40PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 01/29/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2009
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENF-V2 SN.(B)(6) .OTV-S40PRO SN.(B)(6).
• Patient Sex: Unknown