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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE XENON LIGHT SOURCE Back to Search Results
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".
 
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Brand NameEVIS LUCERA ELITE XENON LIGHT SOURCE
Type of DeviceXENON LIGHT SOURCE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
MDR Report Key7817455
MDR Text Key118557881
Report Number8010047-2018-01650
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
Number of Events Reported1
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 Received08/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLV-290SL
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2019
Is This a Reprocessed and Reused Single-Use Device? No

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