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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-290
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2018
Event Type  malfunction  
Manufacturer Narrative
The subject clv-290 has been returned to olympus medical systems corp. (omsc) for evaluation, however the evaluation is in progress at this time. The exact cause of the reported event could not be conclusively determined at this time. The clv-290 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
During the procedure of peg (percutaneous endoscopic gastrostomy), the error "e202" occurred and the endoscopic image was disappeared. ¿e202¿ is the error that ¿the light source has broken down¿. The user replaced the subject clv-290 with the similar device, and completed the procedure. There was no report of the patient¿s injury regarding this event.
 
Manufacturer Narrative
Olympus medical systems corp. (omsc) investigated the subject clv-290 and could reproduce the reported phenomenon. As a result of investigation, the motor of the rgb filter unit was broken in the subject clv-290. Therefore, it is considered that an error occurred because the rgb filter unit was not set at an appropriate position and could not operate correctly. Omsc surmised that failure of the motor of the rgb filter unit was attributed to the following. -aging degradation -the usage environment of the facility, such as the ingress of the dust. The clv-290 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.
 
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 Key8127795
MDR Text Key129899289
Report Number8010047-2018-02367
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
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 Received12/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLV-290
Was Device Available for Evaluation? Yes
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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