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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 Poor Quality Image (1408)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/08/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was not returned to olympus for evaluation. Troubleshooting was performed and the reporter was advised to check various setting, however, the reporter was not able to complete troubleshooting during the phone call. The reporter indicated they would call back if the issue persists to continue troubleshooting. Multiple attempts to contact the customer were made with no response. As the device was not returned for evaluation, we are unable to determine a root cause for the reported event. If additional information becomes available or the device is returned for evaluation, a supplemental report will be filed.

 
Event Description

The user facility reported that the image is freezing when attempting to capture images from the cv-180 to provation. Customer jonathan lui called in reporting that when the customer attempts to capture images from the cv-180 to provation platform. There was no patient harm reported for this report.

 
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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 Key10626569
MDR Text Key209802530
Report Number8010047-2020-07216
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,USER F
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 10/05/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/05/2020
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? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/08/2020
Was Device Evaluated By Manufacturer? No
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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