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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); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 04/27/2020
Event Type  Malfunction  
Manufacturer Narrative

The subject device was not returned for evaluation. On a follow up communication with the technical support engineer, the reporter conveyed that the reported issue was resolved. The reporter did not provide further information as to how the issue was resolved, however, it is likely that the issue was resolved by changing to a new cable as the reporter stated during the incident and troubleshooting that he will obtain another video cable and will report back to the technical support engineer if he was able to resolve the issue. To date there are no other issues reported regarding the incident. If additional information becomes available this report will be supplemented accordingly.

 
Event Description

It was reported that cv-180 device release switched button was not working correctly. According to the reporter while attempting to perform the troubleshooting and pulled up the device menu, the user was unable to view the image on the procedure monitor. Per the user he was on the correct input utilizing the composite output of the video system to the lcd monitor oev-262h input when the no image occurred. There was no patient involvement reported on this event. No user impact or injury reported due to the 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 Key10078350
MDR Text Key208362179
Report Number8010047-2020-02838
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 10/01/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/21/2020
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 Received09/03/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/24/2008
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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