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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE

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SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE Back to Search Results
Model Number CLV-190
Device Problems Loss of Power (1475); Intermittent Loss of Power (4016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/14/2023
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus and evaluated.The customer allegation could not be confirmed.The unit did not power off during the burn-in testing and functioned properly according to the technical guide.It was noted that the device had minor cosmetic wear and tear.The investigation is ongoing.Additional information was requested regarding the event; however the customer responded that the requested information is unknown.A supplemental report will be submitted upon completion of investigation or if any additional information is provided by the user facility.
 
Event Description
The customer reported to olympus, the evis exera iii xenon light source shut down during a diagnostic procedure.There were no reports of patient harm associated with the event.
 
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 specific cause of phenomenon could not be identified as the reported issue was not reproduced during evaluation.Olympus will continue to monitor field performance for this device.
 
Manufacturer Narrative
This supplemental report is being submitted to provide corrections for the initial mdr corrected fields: h6: medical device problem 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)
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 Key17698628
MDR Text Key322833407
Report Number3002808148-2023-09505
Device Sequence Number1
Product Code NWB
UDI-Device Identifier04953170298868
UDI-Public04953170298868
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131780
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup,Followup
Report Date 10/25/2023
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-190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2023
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/15/2023
Initial Date FDA Received09/07/2023
Supplement Dates Manufacturer Received10/06/2023
10/17/2023
Supplement Dates FDA Received10/11/2023
10/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2018
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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