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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 Sparking (2595)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to olympus medical systems corp. (omsc) for evaluation. Omsc evaluated the subject device, and the reported failure phenomenon could not be reproduced. There was no evidence of spark in the subject device. As a result of the investigation, omsc judged that the subject device meets the specification. However, it was confirmed that dusts accumulated in the subject device. The device history record was reviewed and found no irregularities. Based on the investigation result, it was surmised that the possible cause of the reported failure phenomenon was spark occurred for a moment between dust and electrodes in the subject device at turning on the subject device. The clv-290 instruction manual states the corresponding method when there is an abnormality for the device.
 
Event Description
It was reported that the user seemed that the spark with the subject device occurred at unspecified timing. There was no patient injury reported. No further information was provided.
 
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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 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key9488258
MDR Text Key209011087
Report Number8010047-2019-04403
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 12/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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