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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II VIDEO SYSTEM CENTER
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SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II VIDEO SYSTEM CENTER Back to Search Results
Model Number CV-180
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2024
Event Type  malfunction  
Event Description
It was reported the that the image of the video system center was flickering.The issue occurred during preparation for use for a diagnostic, gastrointestinal procedure.The intended procedure was cancelled.There were no reports of patient harm.
 
Manufacturer Narrative
The device was returned to olympus for evaluation and the evaluation found that there was no endoscopic image and the characters on the monitor had noise due to a defective printed circuit board.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.Based on the results of the investigation, it is presumed that due to failure of the printed circuit board, the image flickered and was not displayed.However, a definitive root cause could not be determined.The defect is not caused by misuse of the user, thus the confirmation of the contents of the instruction manual was not applicable.Olympus will continue to monitor field performance for this device.
 
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Brand Name
EVIS EXERA II 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 961-8 061
JA   961-8061
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18668704
MDR Text Key335307918
Report Number3002808148-2024-01219
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeVM
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/08/2024
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 NumberCV-180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/17/2024
Initial Date FDA Received02/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
CLV-180 / EVIS EXERA II XENON LIGHT SOURCE
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