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

Model Number CLV-190

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Due diligence for additional information was executed.Supplemental report(s) will be filed as the information becomes available.The device has been returned and a device evaluation completed for it.Manufacture date is not known.The user¿s complaint was confirmed.Upon inspection and testing, it was observed that the igniter of the device was faulty and would not light the main lamp.This caused the e103 error.There was no other issue observed.The device was equipped with new type switch, normal wear on scope socket and housing.Olympus lamp less than 50 hours, light and air output within specifications.

Event Description

As reported for this event, during set up the device was causing e103 lamp light error message.The lamp did not ignite and switched over to the spare lamp.The lamp was new and used only twice.There is no patient involvement.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Please see the updates in sections: g4, g7, h2, h4, and h10.The device history record review confirmed that device conformed to specifications when shipped.There is no repair history for the 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: 10312499
• MDR Text Key: 200061225
• Report Number: 8010047-2020-04752
• Device Sequence Number: 1
• Product Code: NWB
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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: No Information
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 12/07/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1