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

Model Number CLV-190

Device Problem Communication or Transmission Problem (2896)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the light source had a b30 scope communication error.The issue occurred during preparation for use.There were no reports of patient harm.

Event Description

It was reported, that during preparation for an unknown procedure, the light source displayed a b30 scope communication error.The intended procedure was completed in a different room with a similar device with no delay, there were not reports of patient harm.While speaking with the olympus technical assistance center (tac), the customer was directed to clean the gold contacts in the scope with a lint-free prep pad and alcohol.The customer stated that they had already tried and also tried to use the scope on a different tower, and it had worked fine.Tac asked the customer to confirm connections between the maj-1933/digital light source cable and the maj-1941/light source cable and confirmed that the cables were in good condition and fully inserted.Tac then asked the customer if they had tried other scopes, and they reported that they had tried three scopes with the same result.Tac then advised the customer that this scope would need to come in to olympus for service.The customer was transferred to service and repair.Tac confirmed with the customer that the scope connectors were cleaned, tested on another tower, and are working fine.Tac also confirmed cabling was tested on other scopes of the tower; three scopes were not working.Subsequently, the customer stated that the subject device would not be returned because they had figured out the problem.No additional information was provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.Corrected fields: d9.New information added to the following fields: b5, h4 and h6.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, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.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: 18822231
• MDR Text Key: 337638905
• Report Number: 3002808148-2024-01966
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• 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