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

Model Number	CLV-S200-IR
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
It was reported to olympus field service engineer (fse), that the visera elite ii xenon light source front panel was blinking.And continued turning on.It was also noted, that the emergency lamp indicator was blinking, and made an abnormal sound.The issues were found during maintenance of the device at the site.There were no reports of patient harm associated with the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, it was determined that ¿all led on the front panel continued to light up¿ and the ¿emergency lamp indicator blinked¿ at the same time due to faulty patient circuit (cr) board.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA ELITE 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: 16935315
• Report Number: 3002808148-2023-04847
• Device Sequence Number: 14882525
• Product Code: OWN
• UDI-Device Identifier: 04953170428142
• UDI-Public: 04953170428142
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K200542
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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-S200-IR
• Was Device Available for Evaluation?: Yes
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2018
• 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