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

Model Number CLV-190

Device Problems Electrical /Electronic Property Problem (1198); Overheating of Device (1437)

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

Event Date 03/24/2023

Event Type  malfunction  

Event Description

The customer reported that the evis exera iii xenon light source emergency lamp kept turning on during an unknown procedure.In addition, it was reported that the lamp kept getting "hot" and turning off with "beeping noise" heard.The procedure was completed with a 5¿10-minute delay.There were no error codes reported and there were no reports of patient harm.

Manufacturer Narrative

The device was evaluated, during the process the customer¿s allegation was confirmed, the lamp didn¿t light, and emergency lamp was blinking.Additional findings include the following: bottom chassis, front panel chassis, front panel inside board and top cover are corroded, heavy dust inside unit, the lamp keeps getting hot and turning off the unit and beeping noise due to faulty lamp housing fan and clogged air vent, and bad scope socket debris inside.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if additional information becomes available.This report is related to and linked to the following patient identifiers and submitted medwatch¿s: (b)(4).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the faulty lamp housing fan and dust clogged in the air vent were confirmed.It was determined that the internal temperature increased, and the thermal switch was activated as a result, causing the lamp to be switched to the emergency lamp.It was noted that clv-190 has a thermal switch.If the internal temperature exceeds the requirements, the switch will be turned off, the power supply to the lamp will be shut off (switches to the emergency lamp), and the device generates alarm sound.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.The instruction manual of clv-190 (drawing number: gt7243) describes the following, and the reported phenomenon might be prevented by following the descriptions.¿[important information ¿ please read before use].Avoid using the light source in a dusty environment.This may damage the light source.¿ ¿[3.3 installation of equipment] ·keep the ventilation grills of the light source clear.The ventilation grills are located on the rear panels.Blockage can cause overheating and equipment damage.·clean and vacuum dust the ventilation grills using a vacuum cleaner.Otherwise, the light source may break down and gets damaged from overheating.¿ 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: 16792883
• MDR Text Key: 313819757
• Report Number: 3002808148-2023-04096
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

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: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/23/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2019
• 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