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

Model Number	CLV-S200-IR
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
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 during maintenance, the visera elite ii xenon light source when turned on, its emergency lamp would blink but the lamp does not switch on.There was no report of patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.   new information added to the following fields: d9, h3, h4, h6.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.    the device was returned to olympus for inspection, and the customer's complaint was confirmed.  in addition, the following non-reportable malfunctions were found during the device evaluation: -top cover deteriorated.-rear panel deterioration.-noise is heard due to the life of the power supply unit.-chassis deterioration.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the emergency light does not work due to its life expectancy.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: 18064458
• Report Number: 3002808148-2023-12221
• Device Sequence Number: 7499654
• Product Code: OWN
• UDI-Device Identifier: 04953170428142
• UDI-Public: 04953170428142
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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?: Device Returned to Manufacturer
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2018
• 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