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

Model Number	CLV-S45
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the visera elite xenon light source, the lamp switches to emergency light even after lamp replacement.The issue occurred after the device was turned on.There were no reports of patient or user harm associated with this event.  .
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found: the lamp does not light up due to a converter failure, and the lamp switches to emergency lighting, the output connector (light guide connector) is worn out, causing the connection to rattle, rear panel corrosion, top cover corrosion, rust, chassis corrosion, and rear panel terminal area corrosion.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
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 confirmed that the cause of the phenomenon, ¿the lamp switches to emergency lighting¿, was converter failure.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured.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: 16939611
• Report Number: 3002808148-2023-04867
• Device Sequence Number: 18005121
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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-S45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2010
• 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