Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 LUCERA ELITE XENON LIGHT SOURCE
  • 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 LUCERA ELITE XENON LIGHT SOURCE Back to Search Results
Model Number CLV-290SL
Device Problems No Display/Image (1183); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.
 
Event Description
During the preparation for a gastroscopy using the subject device, an endoscopic image was not displayed on the monitor.The user found that there was rust on the electrical contacts of the output socket of the subject device.The user replaced the subject device to another unspecified device to complete the procedure.There was no report of the patient injury other than replacing the device.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Olympus re-evaluated the event reported in the initial report and determined that the failure mode is not a mdr reportable malfunction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EVIS LUCERA ELITE XENON LIGHT SOURCE
Type of Device
XENON LIGHT SOURCE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key10249358
MDR Text Key199063515
Report Number8010047-2020-04045
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 12/03/2020
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 No Information
Device Model NumberCLV-290SL
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/12/2020
Initial Date FDA Received07/09/2020
Supplement Dates Manufacturer Received11/05/2020
Supplement Dates FDA Received12/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-