• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER Back to Search Results
Model Number CV-180
Device Problem Electrical Power Problem (2925)
Patient Problem No Patient Involvement (2645)
Event Date 06/29/2020
Event Type  Malfunction  
Manufacturer Narrative

Device has been returned for evaluation. The customer¿s complaint of front panel flashing was confirmed. The service technician observed the issue was due to a faulty dp board. Unit was functioning normally with our test dp board. In addition, a worn out video connector was causing poor connection, pc card reader was damaged, and pip cable was corroded. Parts were replaced. Minor wear on front panel and rear panel. Unit passed electrical leak test and all functional tests. All video output signals and images tested okay. Unit has up to date nbi and software version. The cause can be attributed to an electrical component failure. No further information was reported.

 
Event Description

The customer reported to olympus that front panel of the device was blinking. There was no patient injury reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10315891
MDR Text Key200483392
Report Number8010047-2020-04757
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/23/2020
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 Received12/03/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/25/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-