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

Model Number CLV-S190

Device Problems Image Display Error/Artifact (1304); No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported to olympus that the visera elite xenon light source white balance sometimes cannot be obtained, abnormal noise during white balance and an led lighting problem.There were no reports of patient harm associated with this event.Additional information has been requested regarding this event; however, it has not been received.

Manufacturer Narrative

The device was returned to olympus for a device evaluation and the customer¿s allegation was not confirmed.The phenomenon described could not be reproduced.The device evaluation found that there was an led light problem, white balance is sometimes not available, abnormal noise during white balance, and detection lever wear high brightness not enabled.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to b5 of the initial mw with information inadvertently left off.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 investigation, the led lighting failure phenomenon pointed out is due to the panel malfunction (led display does not light up) in the service manual.A root cause could not be identified.Olympus will continue to monitor field performance for this device.

Event Description

Information obtained identifies the phenomenon occurred during inspection for use.No additional has been provided.

• Brand Name: VISERA ELITE XENON LIGHT SOURCE
• Type of Device: 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: 16811679
• MDR Text Key: 313999606
• Report Number: 3002808148-2023-04180
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

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
• Device Operator: Health Professional
• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 05/17/2023
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1