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

Model Number CLV-190

Device Problems Break (1069); Failure to Power Up (1476); Output Problem (3005); No Visual Prompts/Feedback (4021)

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

Event Date 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was partly confirmed, the main and spare lamp did work.However, the device evaluation found the output connector was broken and could not be connected likely due to excessive stress to the output socket.Due to the output socket being crushed, the suction connector could not be connected securely.Furthermore, the lamp socket was broken.Additionally, the error code e103 was displayed due to igniter failure, the igniter was burnt.The heat sink unit was not correctly mounted and that caused the sink spring to be burned.And the device was dusty.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the xenon lamp doesn't work, the emergency lamp is lit up on the evis exera iii xenon light source.There were no reports of patient or user harm associated with this event.

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.Corrected fields: e1 (phone number inadvertently missed), e2/e3 (inadvertently missed), h6 (component code and problem codes were inadvertently missed on the initial for the new reportable events found during evaluation), h6 (problem code changed from no visual prompts to failure to power up for the customer reported issue of lamp does not work).H10 correction: the customer reported issue was not confirmed, the main lamp worked.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over four (4) years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.The cause of the customer reported event, lamp doesn't work, could not be specified as the issue was not reproduced.In regards to the e103 error, it is likely the event occurred due to a faulty ignitor board.Lastly, it is likely the output connector broke due excessive stress, which prevented the scope from being connected.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: 18139067
• MDR Text Key: 328148100
• Report Number: 3002808148-2023-12891
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

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: 10/25/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2019
• 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