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

Model Number CLV-190

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

In speaking with olympus technical assistance center (tac), the customer reported the issue with the intermittent image, where instead of color bars when the scope was plugged in, there was a blackout screen.The customer admitted they were not turning off the tower before swapping out scopes.The tac representative explained to the customer that this could be causing his issues.The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the evis exera iii xenon light source had an intermittent no image issue.There were no reports of patient harm.

Event Description

It was reported, the evis exera iii xenon light source had an intermittent no image issue.The issue occurred during a therapeutic laparoscopic cholecystectomy.The procedure was completed with the same device, however there was a 15-minute delay.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.B5 and h4 were corrected as there were incorrectly selected in the initial mdr.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue was identified.The device was not returned to olympus for inspection.A definitive root cause could not be determined.Olympus will continue to monitor the field performance of 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: 19022894
• MDR Text Key: 339229068
• Report Number: 3002808148-2024-03082
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/02/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 06/25/2024
• Supplement Dates FDA Received: 07/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2019
• 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