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

Model Number CLV-290SL

Device Problem Display Difficult to Read (1181)

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

Event Date 08/10/2018

Event Type  malfunction  

Manufacturer Narrative

The subject clv-290sl was not returned to olympus medical systems corp. (omsc). The user will not return the subject clv-290sl. The clv-290sl instruction manual states the corresponding method when there is an abnormality for the device. There were no further details provided. If significant additional information is received, this report will be supplemented.

Event Description

The user used the subject clv-290sl and the unspecified monitor in the unspecified procedure. During the procedure, the color of the image displayed on the monitor turned green. The user replaced the subject clv-290sl with the similar device and completed the procedure. There was no report of the patient's injury regarding this event.

Manufacturer Narrative

The subject cv-290sl was not returned to olympus medical systems corp. (omsc) for evaluation, therefore omsc cannot evaluate the subject cv-290sl. Omsc checked the device history record of the subject cv-290sl, there was no irregularity found. According to additional information from field service engineer, the facility is continuing to use the subject cv-290sl. Therefore the subject cv-290sl had not malfunction. Omsc consider that this phenomenon is attributed to the inappropriate handling by the user. The cv-290sl instruction manual states the appropriate handling and the counter measures against abnormalities. There were no further details provided. If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• 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
• MDR Report Key: 7817455
• MDR Text Key: 118557881
• Report Number: 8010047-2018-01650
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CLV-290SL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No