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

Model Number	CLV-S400
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the visera 4k uhd xenon light source's high intensity function was not working properly and that the switch was loose and not working properly as well.The issue was found during preparation for use.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: faulty scope detection slide.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation also found minor cosmetic wear and tear and that the unit doesn't recognize that a scope is actually connected due to a faulty scope socket.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.As part of the investigation, olympus followed up with the user facility and obtained additional information regarding the customer's reported event.The customer further reported there was no error message displayed.The high intensity lever was the only indicator of an issue.There was no patient involvement at the time the customer¿s reported issue was observed.No delay, and the staff was able to complete the intended procedure was the same unit.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, it is presumed that scope cannot be recognized due to wear of slide switch.Olympus will continue to monitor field performance for this device.
Event or Problem Description
There was no error message displayed.The high intensity lever was the only indicator of an issue.There was no patient involvement at the time the customer¿s reported issue was observed.No delay, and the staff was able to complete the intended procedure was the same unit.

• 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 (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: 17987708
• Report Number: 3002808148-2023-11612
• Device Sequence Number: 8171318
• Product Code: NWB
• UDI-Device Identifier: 04953170374531
• UDI-Public: 04953170374531
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

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-S400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2020
• 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
• Patient Sex: Unknown