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

Model Number CLV-190

Device Problem Device Alarm System (1012)

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

Event Date 09/28/2022

Event Type  malfunction  

Event Description

The customer reported that his olympus evis exera iii xenon light source was presenting an e300 scope communication error and had indicator leds blinking.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

The customer called olympus technical assistance center (tac) personnel to report his issue.During the call tac recommended a few trouble-shooting options for the customer, but he was not in front of the device at that time and intends to troubleshoot later and follow up with the results.At this time, no return call has been received.However, the subject device was returned, and an initial evaluation was performed.During the initial evaluation, the user¿s report was confirmed ¿ the e300 error was present, and all leds were blinking.A faulty scope socket was found and caused the reported failures.Additionally, there was physical damage noted on the device.The top cover was rusted as were the lamp door and chassis.It was also noted that a non-olympus lamp was recently installed and was missing a washer.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 4 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the event was reproduced, and the cause was determined to be a failure of the scope detection switch.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The instruction manual identifies the following related verbiage which could have prevented the phenomenon: ¿[3.1 precautions for installation and connection].Never apply excessive force to connectors.This could damage the connectors.Use the light source only under the conditions described in ¿transportation, storage, and operating environments¿ on page 105 and, ¿specifications¿ on page 105 in the appendix.Improper performance, compromised safety, and/or equipment damage may result.[7.2 storage].Store the equipment at room temperature in the horizontal position in a clean, dry, and stable location.¿ 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15631983
• MDR Text Key: 302433159
• Report Number: 3002808148-2022-03320
• 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: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

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: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2018
• 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