• 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 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 EXERA II XENON LIGHT SOURCE Back to Search Results
Model Number CLV-180
Device Problem Optical Discoloration (2999)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The subject device clv-180 was not returned to olympus medical systems corp. (omsc). Omsc analyzed the dhr of the subject clv-180, no abnormality was found. The instructions for use of the clv-180 include warnings or cautions describing how to handle the subject device when any irregularity is observed. Omsc has not been identify the cause of this malfunction. Omsc estimates that the cause of the subject event is applicable to one of the following: the optical filter inside the clv-180 did not operate properly due to aged deterioration or the like. The image processing board inside the clv-180 malfunctioned due to aged deterioration or the like. The video signal of the scope was not properly transmitted to the clv-180 due to aged deterioration or the like.
 
Event Description
During an unspecified procedure of endoscopic photodynamic diagnosis (pdd) using the clv-180, the color of the entire endoscope image changed. The user replaced the clv-180 with an unspecified similar device and completed the procedure. While replacing the clv-180, the procedure was interrupted for a while and the procedure prolonged. There was no report of the patient¿s injury regarding this event.
 
Manufacturer Narrative
This supplemental report is submitting to correct "device product code".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEVIS EXERA II XENON LIGHT SOURCE
Type of DeviceXENON LIGHT SOURCE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
MDR Report Key7730496
MDR Text Key115651315
Report Number8010047-2018-01483
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
PMA/PMN Number
K072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLV-180
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2019
Is This a Reprocessed and Reused Single-Use Device? No

-
-