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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 Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2021
Event Type  malfunction  
Manufacturer Narrative
The light source referenced in this report was not returned to olympus for evaluation.However, olympus technical assistance center representative troubleshooted the reported issue with the customer over the phone.Based on the troubleshooting performed the customer reported that the communication error was attributed to the colonoscope and no problem was found with the light source.The colonoscope was returned for service.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported to olympus that, the evis exera iii xenon light source had a communication error code b30 when connected to 190 scopes.There was no harm or user injury reported due to the event.
 
Manufacturer Narrative
The light source referenced in this report was not returned to olympus for evaluation.However, olympus technical assistance center representative troubleshooted the reported issue with the customer over the phone.Based on the troubleshooting performed the customer reported that the communication error was attributed to the colonoscope and no problem was found with the light source.The colonoscope was returned for service.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported to olympus that, the evis exera iii xenon light source had a communication error code b30 when connected to 190 scopes.There was no harm or user injury reported due to the event.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation and the initial reporter's title in sections e2 and e3.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, there was no issue associated with the light source.It was unclear if the phenomenon would be duplicated because the subject device was not returned from the facility.Olympus will continue to monitor field performance for this device.
 
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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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key13120156
MDR Text Key285167178
Report Number8010047-2021-16983
Device Sequence Number1
Product Code NWB
UDI-Device Identifier04953170298868
UDI-Public04953170298868
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
CLASS2-EXMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
190 SERIES UNKNOWN SERIAL AND LOT NUMBER; CF-HQ190L - SERIAL (B)(6)
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