• 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 Erratic or Intermittent Display (1182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned for investigation.Upon inspection of the cv-180 processor, the reported issue of losing signal was not confirmed.A three-hour burn-in test was performed and the unit functioned normally.Furthermore, all video output signal and images test was satisfactory and the unit has an updated narrow band imaging.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
 
Event Description
It was reported the evis exera iii video system center is intermittingly losing signal to the monitor when using the rgb maj-1584 cable.The device must be turned on/off to retrieve signal.There was no patient involvement, no harm or user injury reported due to the event.
 
Manufacturer Narrative
This follow up report is being submitted to include the device history record(dhr) review and results from the legal manufacturer investigation.The following sections were updated: d8, h4, h6 and h10.The legal manufacturer performed the dhr review for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.Since the subject device was manufactured more than fourteen years ago and was used repeatedly for a long period of time, a presumed temporarily malfunction occurred due to aging deterioration of the image board or a defect occurred due to incorrect setting and connection.The instructions for use (ifu) states: all cables must be connected correctly and completely.If you use the device with an incomplete connection, not only will the device not function correctly, but there is a risk of it being damaged.Olympus will continue to monitor complaints for this device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12032660
MDR Text Key277423371
Report Number8010047-2021-07774
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 company representative,user f
Type of Report Initial,Followup
Report Date 07/01/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/27/2021
Initial Date FDA Received06/21/2021
Supplement Dates Manufacturer Received06/29/2021
Supplement Dates FDA Received07/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
RGB MAJ-1584
-
-