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

Model Number CLV-190

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, that the device was displaying an e101 error.The reported problem was found during a diagnostic colonoscopy procedure.Which was completed successfully with the same device.There was no harm or user injury reported due to the event.

Manufacturer Narrative

The device was not returned to olympus for evaluation.But a field service engineer (fse) was onsite where the customer's complaint was confirmed.The fse cleaned the inside of device, including the fans, to ensure proper operation.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, the error is for temperature, when the internal temperature of the light source unit has risen, and the safety mechanism is operating.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 (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17130497
• MDR Text Key: 317237811
• Report Number: 3002808148-2023-05968
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2023

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VIDEO-COLONOSCOPE CF-Q165