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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 Problem No Patient Involvement (2645)
Event Date 08/03/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was not returned to olympus for evaluation. The user¿s complaint was not confirmed. The user advised that it was determined that the cv-180 was the issue and was given instruction to contact the national service center for the repair portal. No findings are available. The cause could not be confirmed. No further information was reported. A supplemental will be submitted if new information becomes available or the device is returned.

 
Event Description

The user facility reported that there was no image on the display monitor connected to the cv-180. The biomed stated that the display screen turned green and then the image was black. There was no video input message on the oev-191 monitor. There was no scope connected and confirmed that there were no color bars displayed on the monitor. It was confirmed that the maj-1462 video cable was connected from the monitor out terminal on the cv-180 to the rgb component a /video/yc input terminals on the oev-191 monitor. All of the lights on the front panel of the cv-180 were illuminated. The biomed was advised to hold the shift button and press f1 on the cv-180 keyboard but he could not see any type of menu. The biomed advised that he was going to get a different video cable and monitor and call back into the technical assistance center if he needed further support. There was no patient involvement. No additional information was provided.

 
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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 Key10471063
MDR Text Key225384677
Report Number8010047-2020-06013
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,HEALTH
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 01/12/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2020
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/27/2010
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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