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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 Type  Malfunction  
Manufacturer Narrative

The device was returned to olympus for evaluation. The evaluation confirmed the user¿s report of ¿intermittent image problem. ¿ the image flickered when the video cable is wiggled, and this was attributed to a worn out connector pins inside the video connector. No other issue was found with the device. This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes. A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

 
Event Description

As reported for this event, there was an intermittent image issue with the device. When the paddle is plugged in, the image goes out with any wiggling. There is no patient involvement. The device was inspected and no abnormalities were observed.

 
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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 Key10360178
MDR Text Key206366324
Report Number8010047-2020-05212
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 COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/21/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/03/2020
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? Device Returned To Manufacturer
Date Returned to Manufacturer04/12/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/03/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/24/2011
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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