MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA ELITE II XENON LIGHT SOURCE

Model Number	CLV-S200-IR
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.Upon evaluation of the device, the reported issue of dark image and the lamp turning off was confirmed.There was no abnormality in the appearance.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 the visera elite ii xenon light source image became too dark and blacked out.In addition, the lamp was off.The event occurred during a chest procedure and a similar device was used to complete the operation.There was no patient harm or user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation a review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, a root cause could not be identified.No abnormalities were found in the operation or logs of the equipment in question, hence, it was believed that the equipment itself is not at fault.However, the possibility cannot be ruled out that the phenomenon may have been caused by the slightly low amount of heat compound applied to the lamp, which may have affected its heat dissipation performance.The logs for one month before and after the occurrence of the phenomenon were checked and it was confirmed that no traces of the error remained.The operation of the equipment was also checked, and no abnormality was found.The amount of heat compound applied appeared to be slightly low when the lamps were checked.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): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13713332
• Report Number: 8010047-2022-04177
• Device Sequence Number: 20452270
• Product Code: OWN
• UDI-Device Identifier: 04953170386138
• UDI-Public: 04953170386138
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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
• Date Returned to Manufacturer: 02/16/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2019
• 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: MAJ-1817.
• Patient Sex: Unknown