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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 Failure to Power Up (1476)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/20/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus repair center for evaluation.The evaluation of the device confirmed the followings; the reported event was reproduced.Defect of the power supply unit was noted.The reported event was caused by the defect.If additional information becomes available, this report will be supplemented.
 
Event Description
During preparation for use, the device failed to start up.There was no report of patient injury associated with this event.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event could not be conclusively determined.Omsc assumed that the power supply unit was accidentally broken.If additional information becomes available, this report will be supplemented.
 
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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 Key10578303
MDR Text Key223647543
Report Number8010047-2020-06806
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 11/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCV-180
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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