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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 Problems Gas Output Problem (1266); No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2018
Event Type  malfunction  
Manufacturer Narrative
The subject clv-260sl does not return to olympus. There were no further details provided. If significant additional information is received, this report will be supplemented.
 
Event Description
During the unspecified procedure with the clv-260sl, the air feeding of the subject clv-260sl through the unspecified endoscope could not be operated. The user replaced the subject clv-260sl to an unspecified similar system and completed the procedure using the same endoscope. There was no report of the patient¿s injury regarding this event. The local service engineer reported the following evaluation result of the subject clv-260sl. The excessive dust collected inside the subject clv-260sl. The air pump incorporated in the subject clv-260sl was faulty. The phenomenon that the user mentioned was reproduced.
 
Manufacturer Narrative
This is a supplemental report for mfr report #8010047-2018-02569. The subject clv-260sl was not returned to olympus medical systems corp. (omsc). The root cause of this event could not be conclusively determined, because omsc could not investigate the subject clv-260sl. Omsc checked the device history record of the subject device, and there was no irregularity found. As ten years or more has passed since the manufacture date of the subject clv-260sl, omsc surmised that the air pump incorporated in the subject device was faulty by aging degradation or other. The instruction manual of the clv-260sl states the corresponding method in case of an abnormality.
 
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 Key8198414
MDR Text Key131722821
Report Number8010047-2018-02569
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 Received12/27/2018
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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