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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA 4K UHD XENON LIGHT SOURCE

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SHIRAKAWA OLYMPUS CO., LTD. VISERA 4K UHD XENON LIGHT SOURCE Back to Search Results
Model Number CLV-S400
Device Problem Loss of Power (1475)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2023
Event Type  malfunction  
Event Description
The customer reported to olympus that the visera 4k uhd xenon light source had no power/intermittent power.When it's on startup, it will run for a little bit, then just power off. the issue was found during preparation for the use of an unspecified diagnostic procedure.No additional information is available.There were no reports of patient harm.
 
Manufacturer Narrative
The device was returned to olympus for evaluation, and the customer's allegation was not confirmed.The device evaluation found the igniter was firing normally, and the power switch was working okay.The device was turned on and off several times without any issues.The device evaluation also found a worn-out socket slider switch, causing intermittent use of high intensity mode; the olympus lamp life meter was reading below 50 hours, and the unstable light intensity output measured out of range. minor scratches on the front panel and top cover.  the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
 
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, the root cause was unable to be determined for the reportable event of the power turning off.Olympus will continue to monitor field performance for this device.
 
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Brand Name
VISERA 4K UHD 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 Key17619875
MDR Text Key321937165
Report Number3002808148-2023-08921
Device Sequence Number1
Product Code NWB
UDI-Device Identifier04953170374579
UDI-Public04953170374579
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/27/2023
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-S400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/24/2023
Supplement Dates Manufacturer Received10/27/2023
Supplement Dates FDA Received10/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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