MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA 4K UHD XENON LIGHT SOURCE

Model Number	CLV-S400
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated by (b)(4).The evaluation was unable confirm the reported event.There was no issue found with the device.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
A user facility reported to olympus that, the (b)(6) light source front panel light flashes.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.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, front panel lighting failure due to system failure, front panel blinking does not light or does not turn off since there was no fault found, this repair was cancelled and the device was returned to the customer.We were unable to determine the cause of this phenomenon therefore the the root cause could not be identified.As a result of checking the manufacturing history there was no abnormality in manufacturing or modification.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA 4K UHD 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: 13143074
• Report Number: 8010047-2022-00818
• Device Sequence Number: 14638823
• Product Code: NWB
• UDI-Device Identifier: 04953170374531
• UDI-Public: 4953170374531
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151011
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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-S400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• 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: 12/07/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 01/03/2022
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2018
• 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