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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 Type  Malfunction  
Manufacturer Narrative

The device was returned to olympus and the user facility report was not confirmed. Olympus testing found a faulty front panel, corrosion on pins inside the video connector and faulty board which was resulting in the device not capturing an image. If new information becomes available from the final service activity, a supplemental report will be filed. Olympus will continue to monitor complaints for this device.

 
Event Description

The user facility reported that the cv-180 produced a green screen during a colonoscopy procedure. The reporter stated that there was a 15-20 minute delay in the procedure however, no impact or harm to the patient. The reporter also stated that the procedure was completed with a backup device.

 
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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 Key10705187
MDR Text Key212687826
Report Number8010047-2020-07902
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
Type of Report Initial,Followup
Report Date 01/14/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/20/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberCV-180
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/02/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/18/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2006
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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