MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problems Corroded (1131); Degraded (1153); Mechanical Problem (1384); Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and repair.The user report could not be confirmed.The device was tested with the (b)(4) video processor and 3 different test scopes without an error.However, the evaluation did identify a loose scope socket tab not protecting the socket pins, a worn out socket air joint leaking air, corrosion in the air tubing, and a non-olympus lamp with 300+ hours that had light output within specifications.This event is under investigation.A follow up will be submitted upon receiving additional information.

Event Description

It was reported that during preparation for use, a (b)(4) error code (scope communication error) was displayed for the evis exera iii xenon light source across all of the customer's 190 scopes.The customer further reported that these scopes work properly on other carts.No patient involvement or impact to patient care was reported for this event.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer's investigation.As part of the investigation, a review of the device history record (dhr) was conducted.The review of the dhr did not find any abnormalities or anomalies identified during production.The device evaluation could not confirm the use report.Therefore, it is assumed the scope communication error is due to a defect in another device/component that is not the subject device.The cause cannot be traced to the device.The cause of the evaluation findings of a loose socket tab was traced to wear over time.It has been more than 8 years since the product was manufactured.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): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11263009
• MDR Text Key: 233352842
• Report Number: 8010047-2021-02102
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

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: 12/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1