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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER
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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER Back to Search Results
Model Number CV-180
Device Problems Image Display Error/Artifact (1304); Poor Quality Image (1408)
Patient Problem No Patient Involvement (2645)
Event Date 06/12/2020
Event Type  malfunction  
Manufacturer Narrative
There is no additional information for this event available as yet.The device will not be returned as the issue was resolved with the correct installation of the cables.Supplemental report(s) will be filed as any information becomes available.
 
Event Description
As reported for this event, the device yielded an image that was tinted blue with a monitor out cable to a third-party monitor.The image issue was resolved when the sdi was used as the input to the monitor after the sdi cable was attached to the device.There was no reported patient involvement.
 
Manufacturer Narrative
The device is not returned as the issue was resolved by connecting the cables.As such, an actual device evaluation is not performed.An evaluation is done based on historical records and communication.This supplemental report is being submitted to provide this information.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.As reported for this event, the device yielded an image that was tinted blue with a monitor out cable to a third-party monitor.The image issue was resolved when the sdi was used as the input to the monitor after the sdi cable was attached to the device.There was no reported patient involvement.The device had no malfunction, the image issue was as a result of the customer using the rgb cable instead of the sdi cable when connecting to the monitor.The instructions for use includes the following statements: the color tone of the endoscopic image is unusual.Possible cause: the monitor cable is connected incorrectly.Solution: connect the monitor cable properly as described in section 8.5, monitor on page 170.
 
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Brand Name
EVIS EXERA II VIDEO SYSTEM CENTER
Type of Device
VIDEO SYSTEM CENTER
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key10236250
MDR Text Key223235581
Report Number8010047-2020-03927
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCV-180
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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