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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 Problem No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 07/14/2020
Event Type  Malfunction  
Manufacturer Narrative

Due diligence was executed for this device. The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time. Supplemental report(s) will be filed as the information becomes available. The concomitant third-party monitor was an endovue nds monitor, model number sc-sx19-a1203, serial number (b)(4).

 
Event Description

As reported for this event, during set up the device yielded an intermittent image on the main third-party monitor. Color bars and menu were available and an image came up with the rgb cable reseating. The image intermittent issue was resolved by switching to s-video setting and rebooting the device. There was no patient involvement and no delay of the intended procedure.

 
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Brand NameEVIS EXERA II VIDEO SYSTEM CENTER
Type of DeviceVIDEO SYSTEM CENTER
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key10373106
MDR Text Key201895369
Report Number8010047-2020-05330
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/06/2020
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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/20/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/07/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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