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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 Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The suspect device was returned to olympus for evaluation. The reported problem could not be confirmed. When tested, the device produced an image with no problems noted. However, a worn lock latch mechanism inside the video connector was found, which could cause image related issues.

 
Event Description

A user facility reported to olympus that the olympus cv-180 did not produce an image after scopes were connected. The problem, as reported to olympus, was found on preparation for use. There was no patient injury or harm, associated with the problem, reported to olympus.

 
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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 Key10617342
MDR Text Key210078422
Report Number8010047-2020-07097
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 USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/08/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/01/2020
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? Device Returned To Manufacturer
Date Returned to Manufacturer09/15/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/23/2011
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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