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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA ELITE XENON LIGHT SOURCE

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SHIRAKAWA OLYMPUS CO., LTD. VISERA ELITE XENON LIGHT SOURCE Back to Search Results
Model Number CLV-S190
Device Problems Poor Quality Image (1408); Loss of Power (1475)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there was a dark image issue and both main lamp and spare lamp does not ignite while using the light source.There was no delay or patient harm associated with the event.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: e2.Additional information added to field b5, h4, h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Since the subject device was not returned to olympus, the reported event cannot be confirmed neither the condition of the device.Based on the results of the investigation, it is not possible to establish the root cause.Olympus will continue to monitor field performance for this device.
 
Event Description
The issue was found at the beginning of a diagnostic cystoscopy procedure.The procedure was completed with the same device.
 
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Brand Name
VISERA ELITE XENON LIGHT SOURCE
Type of Device
XENON LIGHT SOURCE
Manufacturer (Section D)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima 961-8 061
JA  961-8061
Manufacturer (Section G)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19015551
MDR Text Key339148605
Report Number3002808148-2024-03054
Device Sequence Number1
Product Code NWB
UDI-Device Identifier04953170301995
UDI-Public04953170301995
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/25/2024
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-S190
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/25/2024
Initial Date FDA Received04/01/2024
Supplement Dates Manufacturer Received04/23/2024
Supplement Dates FDA Received04/25/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/09/2013
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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