MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II XENON LIGHT SOURCE

Model Number	CLV-180
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the light was flickering from the xenon light source during preparation for use.There were no reports of patient harm.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was returned to olympus for inspection, and the customer's reportable malfunction of light flickering in the device was confirmed.Based on the results of the investigation, it is presumed that the event occurred due to faulty turret unit.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Additional information: b5; d10 (concomitant device was reported as "cv-180" [evis exera ii video processor]).
Event or Problem Description
From the results of due diligence with the user facility, the following additional information was provided regarding the suggested phenomenon: 1.What was the intended procedure (name)? unknown 2.Type of procedure (therapeutic or diagnostic)? diagnostic 3.Were any other devices involved in the event? yes a.If yes, please list them and provide model/serial number(s) if possible cv-180 4.Was there any delay in the procedure in which the subject device was used? no a.If yes, how long was the delay and was the patient under general anesthesia? 5.Was the intended procedure completed? yes 6.Was the same device used to complete the procedure? no a.If no, were there other devices used to replace the subject device during the procedure? yes i.If yes, please list the device model(s) and serial/lot number(s) if known cv-180 &clv-180.

• Brand Name: EVIS EXERA 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: 20176676
• Report Number: 3002808148-2024-08553
• Device Sequence Number: 8695927
• Product Code: NWB
• UDI-Device Identifier: 04953170216961
• UDI-Public: 04953170216961
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K133538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2024

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-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 09/18/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/01/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2009
• 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