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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 Erratic or Intermittent Display (1182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2021
Event Type  malfunction  
Manufacturer Narrative
At this time, it is unclear whether the device will be returned or not.The customer would like to attempt trouble-shooting it first before sending it back for any repairs.However, should additional information become available prior to the conclusion of the investigation, a supplemental report will be provided.
 
Event Description
It was reported, the image on the evis exera ii video system center began "flashing and clicking with multiple cameras".According to the initial reporter, the issue wasn't instant, it took a while to occur.There was no patient harm or consequence reported as a result of this event.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr) was conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.Probable cause for the failure is age related wear and breakdown of the lock and pin of the video connector.Another possible cause for this event is the corrosion of the connector caused by leaving dust, dirt or the remainder of the chemical liquid adhered.As a result, the electrical contact of the connector could have become unstable.Olympus will continue to monitor the field performance of this device.
 
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Brand Name
EVIS EXERA II VIDEO SYSTEM CENTER
Type of Device
VIDEO SYSTEM CENTER
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key11436511
MDR Text Key244808698
Report Number8010047-2021-03437
Device Sequence Number1
Product Code FAJ
UDI-Device Identifier04953170215513
UDI-Public04953170215513
Combination Product (y/n)N
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/12/2021
Initial Date FDA Received03/08/2021
Supplement Dates Manufacturer Received03/31/2021
Supplement Dates FDA Received04/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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