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

Model Number CLV-190

Device Problems Device Alarm System (1012); Communication or Transmission Problem (2896)

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

Event Date 09/12/2022

Event Type  malfunction  

Manufacturer Narrative

The device has not been received to date.The customer called the olympus technical assistance center (tac) support to troubleshoot.The customer had the same problem before but forgot how to reset the error code.Tac assisted the customer to press the esc key on the upper le ft corner of the keyboard and the error was able to reset with no further problem.The next scope the customer connected this tower has no more problem.However, with the original scope reconnect to the tower and the b30 error returns.Tac instructed the customer that it is the scope that causes the problem, and this scope needs to be sent in for repair accordingly.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented.

Event Description

The customer reported to olympus, a b30(scope communication error) displayed the evis exera iii xenon light source.The procedure was completed using a similar device.There were no reports of patient harm associated with this event.

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.Approximately 10 years have passed since the device was manufactured.Based on the results of the legal manufacturer's investigation, the cause of the reported issue was likely due to the connected scope.A definitive root cause cannot be identified.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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15556856
• MDR Text Key: 306901355
• Report Number: 3002808148-2022-02876
• 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: CLASS2-EXMPT
• 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: 11/18/2022

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: 09/12/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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