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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA PRO XENON LIGHT SOURCE

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OLYMPUS MEDICAL SYSTEMS CORP. VISERA PRO XENON LIGHT SOURCE Back to Search Results
Model Number CLV-S40PRO
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2021
Event Type  malfunction  
Manufacturer Narrative
The suspect device was not returned to olympus for evaluation.After inspection by the user facility's in-house staff, it was found that the power cord of the device was not connected properly, resulting in "shutdown and blackout." the investigation is ongoing and the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
 
Event Description
A user facility reported to olympus that while performing a transurethral ureteroscopic laser lithotripsy, the image was suddenly lost on the monitor screen.The end user immediately paused the procedure and checked the olympus, model clv-s40pro, visera pro xenon light source, including the power cord and cable connections.The device was restarted and the image was still not present.A delay in procedure occurred of approximately 10 minutes; there was no adverse health effect to the patient attributed to the delay.The intended procedure was completed using a different device.There was no patient injury, associated with the event, reported to olympus.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, a definitive root cause could not be established for this reported phenomenon - as this device was not returned to a repair department, it was not possible to check the status of the product, nor determine whether the phenomenon occurred due to the failure of the device.Olympus will continue to monitor field performance for this device.
 
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Brand Name
VISERA PRO 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 Key13061181
MDR Text Key282633864
Report Number8010047-2021-16639
Device Sequence Number1
Product Code GCT
UDI-Device Identifier04953170228940
UDI-Public04953170228940
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 01/17/2022
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-S40PRO
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/05/2021
Initial Date FDA Received12/22/2021
Supplement Dates Manufacturer Received01/11/2022
Supplement Dates FDA Received01/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age31 YR
Patient SexFemale
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