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

Model Number CLV-190

Device Problem Electrical Power Problem (2925)

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

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the evaluation found that the housing had broken front panel; faulty power supply; faulty scope socket; and screen turned yellow and the ignitor flickered.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed that during the device evaluation, the xenon light source exhibited faulty power supply.There were no reports of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of 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 9 years since the subject device was manufactured.Based on the results of the investigation there was faulty ac/dc power and faulty lamp ignitor.However, root cause of these phenomena could not be identified.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: h4, h6, h10 corrected fields: d8.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that unit did not power on at all due to faulty alternating current/direct current power.Additionally, it was found that the customer used a non-olympus lamp and it's likely the ticking noise occurred from the lamp ignitor when the unit was powered on, and the spare lamp lit up due to faulty lamp ignitor.Three attempts were made to obtain additional information regarding the reported event, but no response was received from the customer olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 18627232
• MDR Text Key: 334882806
• Report Number: 3002808148-2024-01019
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2024

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
• Device Operator: Health Professional
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 02/14/2024; 03/26/2024
• Supplement Dates FDA Received: 02/21/2024; 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2015
• 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