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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 Optical Problem (3001)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2018
Event Type  malfunction  
Manufacturer Narrative
The subject clv-290sl has not been returned to omsc. The user will not return the subject cv-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
During the unspecified procedure, the lamp mounted in the subject clv-290sl went out. The user temporarily suspended the procedure of withdrawing an endoscope from the patient's body. The user replaced the endoscopic system including the subject clv-290sl with another endoscopic system, and completed the procedure. There was no report of the patient¿s injury regarding this event.
 
Manufacturer Narrative
The user has not returned the subject cv-290sl, so omsc cannot investigate the subject cv-290sl. Omsc checked the device history record of the subject cv-290sl, and there was no irregularity found. The root cause of this event could not be conclusively determined, because the subject cv-290sl could not be investigated. However, based on the information omsc obtained so far, omsc surmised that the reported phenomenon, which was the lamp mounted in the subject clv-290sl went out, was caused by temporary malfunction of the electrical component, circuit board, power supply unit, or etc in the subject cv-290sl in theory. 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 Key7730500
MDR Text Key115684770
Report Number8010047-2018-01484
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 Received07/30/2018
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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