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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA ELITE XENON LIGHT SOURCE
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OLYMPUS MEDICAL SYSTEMS CORP. VISERA ELITE XENON LIGHT SOURCE Back to Search Results
Model Number CLV-S190
Device Problem Energy Output Problem (1431)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.Omsc presumed that e207 was caused by the failure of the emergency light.Regarding the cause of the emergency light failure, an accidental failure could be considered from the confirmation result of dhr and delivery date.
 
Event Description
Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus service operation repair center (sorc) on june 7, 2021, it was found that clv emergency error e207 occurred due to emergency light failure.There was no report of patient injury associated with the event.
 
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Brand Name
VISERA ELITE 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 Key12090085
MDR Text Key280582993
Report Number8010047-2021-08170
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 company representative
Type of Report Initial
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCLV-S190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/07/2021
Initial Date FDA Received06/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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