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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 Problems Image Display Error/Artifact (1304); Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 10/21/2020
Event Type  Malfunction  
Manufacturer Narrative

Additional information is not yet available for this event. Supplemental report(s) will be filed as any information becomes available. The device has been returned and a device evaluation completed for it. Manufacture date is not available. The user¿s complaint was confirmed. Upon inspection and testing, it was observed that the front panel and keyboard were not functioning. This is attributed to the faulty power supply. In addition were found, worn out lock latch on video connector causing loss of image when wiggle the pigtail and corroded pip connector.

 
Event Description

As reported for this issue, during preparation for use for an unknown procedure all the device indicators on the front panel were stuck in on position and could not be reset by powering the device off and on. There is no patient involvement and no harm reported to any patient.

 
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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 Key10816745
MDR Text Key224627812
Report Number8010047-2020-08753
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
Report Date 01/11/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/10/2020
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 Manufacturer10/26/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/21/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/24/2006
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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