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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE
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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE Back to Search Results
Model Number CLV-190
Device Problem Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The suspect device was returned to olympus and evaluated.The reported problem of "limited air insufflation" was confirmed and the cause assigned to a worn air joint unit.In addition, the scope socket was found to fail due to the locking mechanism not protecting the pins.
 
Event Description
A user facility reported to olympus that there was "limited air insufflation" when using the device and they were unable to clean the lens.There was no patient injury or harm, associated with the problem, reported to olympus.
 
Manufacturer Narrative
Upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
 
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Brand Name
EVIS EXERA III XENON LIGHT SOURCE
Type of Device
XENON LIGHT SOURCE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key10548846
MDR Text Key207390990
Report Number8010047-2020-06631
Device Sequence Number1
Product Code NWB
Combination Product (y/n)N
PMA/PMN Number
CLASS2-EXMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCLV-190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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