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

Model Number CLV-190

Device Problem Flare or Flash (2942)

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

Event Date 03/27/2023

Event Type  malfunction  

Event Description

An olympus field service engineer(fse) reported on behalf of the customer that the evis exera iii xenon light source's front panel light emitting diodes (leds) were blinking.This occurred during preparation for a diagnostic upper gastroenterology (gi) endoscopy procedure.The procedure was delayed by 5-10 minutes as a result of the reported issue and completed using a different, but similar device.There was no report of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed due to dust being inside the scope sensor.Other findings include heavy dust inside the unit, a damaged temperature harness insulator, a broken scope socket, a dented tank socket, a damaged foot, and a missing hexagonal wrench from the lamp door.Additionally the paint peeled off from the lamp door and top cover, there were hit marks on the front panel, there was minor corrosion on the rear panel and on the chassis, and one screw of the endoscope position detecting unit connector was not fixed properly.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the front panel led continued to flash because of dust inside the unit, or due to a faulty scope socket.However, the root cause 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: 16797582
• MDR Text Key: 313847375
• Report Number: 3002808148-2023-04127
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• 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: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2015
• 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