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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 Corroded (1131); Poor Quality Image (1408); Naturally Worn (2988)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device referenced in this report has returned to olympus for evaluation. Preliminary findings are reported. The definitive cause of the customer's experience cannot be determined at this time. The investigation is ongoing. Physical evaluation of the complaint device reveals: the user's report is confirmed. The image flickers in and out due to worn out video connector pins. The front panel is worn out with minor corrosion on the chassis. The software version is 4. 0. This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
 
Event Description
It is reported while preparing an evis exera ii video system for use, it was found to have an intermittent signal causing the image to flicker in and out. There was no patient contact/impact related to this occurrence.
 
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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 Key11302084
MDR Text Key243689990
Report Number8010047-2021-02431
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133538
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 03/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCV-180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2007
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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