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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 Unintended Power Up (1162)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2022
Event Type  malfunction  
Event Description
A user facility reported to olympus that during preparations to use the evis exera iii xenon light source, the front panel was blinking, flashing, noisy and continuing to turn on.There was no harm or user injury reported due to the event.
 
Manufacturer Narrative
The device was returned to olympus for evaluation.The evaluation did confirm the reported event by the customer that it was noisy and kept blinking.The evaluation uncovered that the device had a faulty scope socket and was sticking intermittently which was causing the front panel to blink continuously.There was minor cosmetic damage, the power switch was updated and had a non-olympus lamp.The faulty parts were replaced.The device was inspected and passed olympus functional standard.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.
 
Manufacturer Narrative
The device was returned to olympus for evaluation.The evaluation did confirm the reported event by the customer that it was noisy and kept blinking.The evaluation uncovered that the device had a faulty scope socket and was sticking intermittently which was causing the front panel to blink continuously.There was minor cosmetic damage, the power switch was updated and had a non-olympus lamp.The faulty parts were replaced.The device was inspected and passed olympus functional standard.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
A user facility reported to olympus that during preparations to use the evis exera iii xenon light source, the front panel was blinking, flashing, noisy and continuing to turn on.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 legal manufacturer's investigation.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.It has been over 6 years, since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the root cause of the front panel flashing loudly and the scope not being detected could not be identified.However, it¿s likely the cause, is related to a faulty scope detection switch.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 Key13508711
MDR Text Key285488708
Report Number8010047-2022-02763
Device Sequence Number1
Product Code NWB
UDI-Device Identifier04953170298868
UDI-Public4953170298868
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 Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/03/2022
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 Health Professional
Device Model NumberCLV-190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/20/2022
Initial Date FDA Received02/10/2022
Supplement Dates Manufacturer Received05/10/2022
Supplement Dates FDA Received06/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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