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

Model Number CLV-S190

Device Problems Break (1069); Output Problem (3005)

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

Event Date 04/10/2023

Event Type  malfunction  

Manufacturer Narrative

During device evaluation at olympus, it was found the complaint was confirmed.And the xenon and halogen lights were not working.Also, evaluation found the white lens was in foggy condition and the front panel cable was corroded.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported, that both lamps and front panel switches of the visera elite xenon light source were not working.The front panel light turned on, but the switches were not working and both lamps were not igniting.The issues were found during maintenance.There were no reports of patient harm.

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 investigation it is likely the intermittent image was caused by a faulty printed circuit board.However, the specific cause of the faulty printed circuit board could not be established at this time.Olympus will continue to monitor field performance for this device.

• 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: 16881596
• MDR Text Key: 314726995
• Report Number: 3002808148-2023-04609
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

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: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2016
• 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