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

Model Number CLV-190

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2020

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned for evaluation.The customer¿s complaint was not confirmed.No findings available.The cause could not be determined.No further information was reported.

Event Description

The customer reported to olympus that during preparation for use, the device's lamp switched to the emergency lamp and a lamp light up error occurred.There was no patient involvement.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.A dhr review was performed for the subject device.A software upgrade was performed prior to release of the device.It was verified the device was manufactured and released in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.Based on the available information, it is deemed likely by the legal manufacturer that the lamp lights did not operate correctly due to deterioration of a component(s) associated with the age of 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: 10080608
• MDR Text Key: 222564847
• Report Number: 8010047-2020-02850
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

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: Health Professional
• Device Model Number: CLV-190
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1