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

Model Number	CLV-S45
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The evaluation uncovered turret malfunction (does not rotate), the xenon lamp consumption (does not light) and the connection was hard due to wear of the output connector (light guide connection part).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, all the lamps on the visera xenon light source keep blinking when the power is turned on during the pre-use inspection.There were no reports of patient harm associated with this event.
Additional Manufacturer Narrative
Additional information has been received from the customer.This supplemental report is being submitted to provide this information as well as additional information based on the legal manufacturer's final investigation.Please see the updates in sections b3, b5, h6, and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 13 years since the subject device was manufactured.Based on the results of the investigation, it is likely the flashes on the front panel occurred due to a malfunction of the turret and that the lamp lighting failure likely occurred due to exhaustion of the zenon lamp.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer provided additional information: date of event, december 12, 2022.The occurrence was confirmed during the pre-use inspection.There was no delay reported.The defect of this product was discovered during the pre-use inspection, so it is not used for the procedure.Not sure if other products were used.
Additional Manufacturer Narrative
H4 (device manufacturer date was incorrect on the initial report), h6 (type of investigation code ¿4110¿ was inadvertently omitted from the previous follow-up report), and h6 (investigation conclusions code on the previous follow-up report was incorrect).

• 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: 16175704
• Report Number: 3002808148-2023-00462
• Device Sequence Number: 11421624
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2023

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: 12/18/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2022
• Supplement Date Received by Manufacturer: 01/25/2023; 04/04/2023
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 02/14/2023; 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2009
• 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