• 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. HALOGEN 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. HALOGEN LIGHT SOURCE Back to Search Results
Model Number CLK-4
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. The exact cause of the reported event could not be conclusively determined. However, based on the information from oekg which the carrying handle was broken out, there was the possibility that the user might have dropped the subject device. Therefore there was the possibility that this phenomenon was attributed to the failure of the lamp due to the mechanical shock when the user dropped the subject device, or the life of the lamp.

 
Event Description

Olympus medical systems corp. (omsc) was informed that during the incoming inspection for repair at the service department of olympus (b)(4) (oekg), it was found that the lamp had failure. In addition, service department of oekg also found the follows. The carrying handle was broken out. The power switch had failure. The around of the power switch of the front panel was broken. The pump capacity exceeds for manufacturer's specification. The output socket was damaged. There was no patient injury associated with this report.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHALOGEN LIGHT SOURCE
Type of DeviceHALOGEN LIGHT SOURCE
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 Key11033638
MDR Text Key227140667
Report Number8010047-2020-10627
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 12/18/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCLK-4
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/19/2020
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 Unkown

-
-