• 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 III 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 III XENON LIGHT SOURCE Back to Search Results
Model Number CLV-190
Device Problems Burst Container or Vessel (1074); Erratic or Intermittent Display (1182); Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2017
Event Type  malfunction  
Manufacturer Narrative
The subject clv-190 was not returned to olympus medical systems corp. (omsc). Omsc checked the dhr of the subject clv-190 and no abnormality was found. Omsc confirmed the following using the document supplied from the complaint initiator. The examination lamp broke. The lens filter in turret unit of the subject clv-190 was damaged. There were fragments of the examination lamp and the dust on the inside of the subject clv-190. The scope socket of the subject clv-190 adhered to the dust. The examination lamp was used for over 500 hours. Omsc could not identify the root cause because the subject clv-190 was not returned to omsc. Based on these investigation results, omsc surmised this phenomenon occurred by the following. The examination lamp deteriorated due to use for over 500 hours. The examination lamp broke by unspecified reason because the examination lamp became brittle by the deterioration. Therefore the emergency lamp ignited instead of the examination lamp. There were no further details provided. If significant additional information is found, this report will be supplemented.
 
Manufacturer Narrative
The subject clv-190 was returned to olympus for investigation. Now investigation is ongoing. The exact cause of the reported event could not be conclusively determined at this time. If significant additional information is received, this report will be supplemented.
 
Event Description
During the unspecified procedure with clv-190, the examination lamp of the subject device went off and the emergency lamp started up. When the technician arrived the examination lamp have exploded and there was internal damage of the subject device. The user facility replaced the subject clv-190 with another unspecified similar device and completed the procedure. There was no report of the patient injury other than replacing the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEVIS EXERA III XENON LIGHT SOURCE
Type of DeviceXENON LIGHT SOURCE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
hiroki moriyama
2951 ishikawa-cho
hachioji-shi, tokyo-to 
8142642517
MDR Report Key6310155
MDR Text Key248930576
Report Number8010047-2017-00141
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK112680
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLV-190
Was Device Available for Evaluation? No
Date Returned to Manufacturer01/24/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-