MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA 4K UHD XENON LIGHT SOURCE

Model Number	CLV-S400
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer¿s allegation was not confirmed.The evaluation uncovered the light guide socket was worn, resulting in occasional no highlight mode and the main lamp was burnt black.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The customer reported to olympus during preparation for a laparoscope procedure, no high light mode and dark image on the visera 4k uhd xenon light source.Upon inspection and testing of the returned unit, lamp failure was found.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.The procedure was completed using a similar device.There were no reports of patient harm associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on 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.Based on the results of the investigation, the definitive root cause of the burnt main lamp could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA 4K UHD 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15774159
• Report Number: 3002808148-2022-04022
• Device Sequence Number: 14231422
• Product Code: NWB
• UDI-Device Identifier: 04953170374531
• UDI-Public: 04953170374531
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151011
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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-S400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2022
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2020
• 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: OTV-S400
• Patient Sex: Unknown