MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE; ENDOSCOPIC LIGHT SOURCE UNIT, LINE-POWERED

Model Number CLV-190

Device Problems Device Emits Odor (1425); Smoking (1585)

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

Event Date 02/14/2023

Event Type  malfunction  

Event Description

A user facility reported to olympus that the evis exera iii xenon light source gave off error message e300 during an esophagogastroduodenoscopy/colonoscopy procedure.After the procedure, the user facility was advised to take canned air and blow out the scope socket connector.Upon use of the canned air, the device made an exploding sound with smoke and a burning smell came from the unit.The user facility thought the lamp may have exploded.It was stated that the procedure was not delayed and there was no patient impact nor intervention required.

Manufacturer Narrative

Upon evaluation of the returned device, the unit failed inspection due to a faulty converter.When the unit was powered on, the burning smell was confirmed to be coming from inside the unit.There was dust buildup inside of the converter and the heatsink assembly.Additionally, the lamp was found to have excessive thermal grease/paste.The light source was tested with a test converter, and it passed functional inspection.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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 8 years since the subject device was manufactured.Based on the results of the legal manufacturer¿s investigation, a definitive root cause of the faulty converter could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: ENDOSCOPIC LIGHT SOURCE UNIT, LINE-POWERED
• 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: 16559115
• MDR Text Key: 311756297
• Report Number: 3002808148-2023-02592
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

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: 02/17/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2015
• 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