• 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 No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The referenced video system unit was returned for evaluation. The unit was inspected, tested and found no image occurred when the video cable was manipulated. A visual inspection noted the video connector lock latch was broken and the video connector could not be connected appropriately. Additionally, the picture in picture connector was corrected. The unit was repaired and returned to the customer. A review of the service history showed the unit was purchased on (b)(6) 2007 with no previous repair records. The cause of the reported event cannot be determined at this time as the investigation is ongoing, however, if additional information becomes available this report will be supplemented accordingly.

 
Event Description

During a standard service inspection of a customer's evis exera ii video system center, no image occurred when the video cable was manipulated. The customer did not report any problems associated with the device and there was no patient injury or harm 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 Key10791098
MDR Text Key214790072
Report Number8010047-2020-08570
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 COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/05/2020
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? Device Returned To Manufacturer
Date Returned to Manufacturer03/17/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/17/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/16/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-