MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE XENON LIGHT SOURCE

Model Number CLV-290SL

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the control panel of the subject device blinked and a clv turret error e200 occurred.The subject device has not been returned to omsc but was returned to olympus trading shanghai limited.(osh).In the evaluation of osh.The following was confirmed, there was no abnormality of the exterior of the subject device, also inside of the subject device such as the evidence of the invasion of water.The rotation of the red, green and blue (rgb) filter unit was abnormal, and the buttons on the front panel were flashed.However the rgb filter unit was replaced to another one, then the subject device worked properly without blinking of the front panel and occurring the error e200.There was no damage of the rgb filter unit.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was not returned to the olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, there was the possibility that this phenomenon was attributed to the distortion of the turret or the damage of the sensor of the turret which was caused possibility by that the excessive force was applied to the turret or around the turret of the subject device.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation result and correct in the initial report submitted on may 15, 2020.The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.However, based on the information from olympus trading shanghai limited, omsc concluded that the reported event was not reportable event.

• Brand Name: EVIS LUCERA ELITE 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: 10060072
• MDR Text Key: 222564562
• Report Number: 8010047-2020-02710
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CLV-290SL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1