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

Model Number	CLV-S40PRO
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The investigation confirmed that there had been a blackout without being output.It was also noted, when the scope and (b)(6), (the related record) were connected to each other, there was no smoke generated.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The customer reported to olympus, the visera pro xenon light source and visera pro video system center generated smoke just prior the end of the examination, and it was further noted that the endoscopic image had no output, resulting in a blackout.The issue was found during the examination and was completed using the same set of equipment.There was no delay in treatment and there were no reports of patient harm.Related patient identifier: (b)(6) visera pro video system center for additional device reported for same event (b)(3).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the reported event could not be identified.However, it¿s likely the cause is related to a malfunction of the power supply unit.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA PRO 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: 17858267
• Report Number: 3002808148-2023-10658
• Device Sequence Number: 5704909
• Product Code: NWB
• UDI-Device Identifier: 04953170228933
• UDI-Public: 04953170228933
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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-S40PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• 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: 09/03/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2012
• 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: ENF-V2 VISERA RHINO-LARYNGO VIDEOSCOPE SN UNKNOWN; OTV-S7PRO VIDEO SYSTEM CENTER (B)(6).
• Patient Sex: Unknown