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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA XENON LIGHT SOURCE Back to Search Results
Model Number CLV-260SL
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2018
Event Type  malfunction  
Manufacturer Narrative
Since the subject device clv-260sl was not returned to olympus medical systems corp. (omsc), the investigation has not been performed for the subject device yet. Confirming the manufacturing record of the clv-260sl, omsc did not find any irregularities in such device. The instructions for use of the clv-260sl includes warnings or cautions describing how to handle the subject device when any irregularity is observed. Omsc has neither performed any investigation into the clv-260l yet nor identified the cause. Omsc estimates that the cause of the subject event is applicable to one of the following: age deterioration of the power supply unit etc. , causes a shortage of the power supply voltage for lighting the lamp; or adhesion of dust to the light guide lens or the deterioration of optical system performance causes the shortage of light quantity.
 
Event Description
According to a report from an user, the light emitted from clv-260sl got dim under an unspecified condition. After the examination lamp was replaced, the light got dim again during the next unspecified procedure. The user decided to discontinue the unspecified procedure. There was no report of the patient¿s injury regarding this event.
 
Manufacturer Narrative
This supplemental report is submitting to correct "device product code".
 
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Brand NameEVIS LUCERA XENON LIGHT SOURCE
Type of DeviceXENON LIGHT SOURCE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
MDR Report Key7505823
MDR Text Key108643098
Report Number8010047-2018-00817
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 health professional,user faci
Type of Report Initial,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLV-260SL
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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