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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VIDEO SYSTEM CENTER

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SHIRAKAWA OLYMPUS CO., LTD. VIDEO SYSTEM CENTER Back to Search Results
Model Number CV-170
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2023
Event Type  malfunction  
Event Description
The customer reported to olympus that during an unspecified procedure, the video system center had insufficient light output from the led lamp.There was no patient harm associated with this event.
 
Manufacturer Narrative
Additional information received from the customer reported the customer had set the light setting to "peak" and switched off the "automatic".Technician checked the settings and the automatic light control was set to "manual" and the aperture to "peak".With the right settings, the functional test was ok and the issue was resolved.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
 
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 7 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, and the inability to evaluate the subject device, a definitive root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.
 
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Brand Name
VIDEO SYSTEM CENTER
Type of Device
VIDEO SYSTEM CENTER
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 Key17875042
MDR Text Key324971348
Report Number3002808148-2023-10787
Device Sequence Number1
Product Code NTN
UDI-Device Identifier04953170338496
UDI-Public04953170338496
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K122831
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/20/2023
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 NumberCV-170
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/06/2023
Initial Date FDA Received10/05/2023
Supplement Dates Manufacturer Received11/17/2023
Supplement Dates FDA Received11/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/03/2016
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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