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

Model Number CLV-190

Device Problems Erratic or Intermittent Display (1182); Mechanical Problem (1384)

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

Event Date 09/21/2023

Event Type  malfunction  

Manufacturer Narrative

During device evaluation at olympus, it was found the complaint was confirmed and the image went out due to a faulty scope socket.The locking mechanism and scope detection slide were not functioning, which caused the front panel to intermittently blink.Evaluation also found the housing had minor cosmetic wear and tear and a non-olympus lamp had 50 or more hours.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the scope image went out when the connector of the evis exera iii xenon light source was manipulated or wiggled.The issue was found when preparing the device for use in a diagnostic colonoscopy procedure.No error messages were displayed and the issue was replicated using multiple scopes.The procedure was completed with a similar device with no delay.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the correction of the initial mdr and the legal manufacturer's final investigation.Additional information: h6: (add a medical device problem code and investigation code).A review of the device history record found no deviations, that could have caused or contributed to the reported issue.For the image problem, when scope is manipulated.Issue a definitive root cause was not identified.However, based on the results of the investigation, the probable cause of the malfunction would likely, be a faulty connector (contact failure or the like).For the front panel blinking constantly, due to the locking mechanism and scope detection slide failure.A definitive root cause was not identified.However, based on the results of the investigation, the probable cause of the malfunction would likely, be the locking mechanism and the scope detection slide did not work.The scope detection function did not work properly.The event can be prevented, by following the instructions for use which state: [warning] non-olympus equipment can cause instability of the automatic brightness adjustment.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: 17918503
• MDR Text Key: 326361707
• Report Number: 3002808148-2023-11175
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

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: 09/28/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 11/14/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• 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