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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 No Display/Image (1183); Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/23/2020
Event Type  Malfunction  
Manufacturer Narrative

Since the subject device has not been returned to olympus medical systems corp. (omsc) for the evaluation, the exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.

 
Event Description

Olympus medical systems corp. (omsc) was informed from the user that the image of the subject device was not displayed and the display color was pink at the preparation for use. At the incoming inspection for the repair, olympus india checked the subject device. (b)(4) found that the subject device could not be started up and all leds on the front panel were blinking continuously due to the printed circuit board failure of the subject device, and the fans of the power supply unit were not worked due to the power supply unit failure of the subject device. There was no report of patient injury associated with this event.

 
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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 Key10731945
MDR Text Key222549869
Report Number8010047-2020-08100
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/24/2020
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
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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