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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 Consequences Or Impact To Patient (2199)
Event Date 04/26/2020
Event Type  Malfunction  
Manufacturer Narrative

The subject device was not been returned to olympus medical systems corp. (omsc) for evaluation. The exact cause of the reported event could not be conclusively determined.

 
Event Description

Olympus medical systems corp. (omsc) was informed from the facility that during preparation for use the noise appeared on the endoscopic image. The service department of olympus (b)(4) checked the subject device and found that the subject device could not start up intermittently and there was no signal output due to the electrical circuit board damaged. There was no report of patient injury associated with this 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 Key10118434
MDR Text Key193997443
Report Number8010047-2020-03104
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeVM
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 06/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/04/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
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 Received05/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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