• 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 Date 08/10/2020
Event Type  Malfunction  
Manufacturer Narrative

The device has not been returned to olympus medical systems corp. (omsc) but was returned to oaz for evaluation. The device was manufactured at least 15 years ago, so omsc was unable to confirm device history record (dhr). The exact cause of the reported event could not be conclusively determined, however there is possibility that the reported event was caused by the life of the device. If additional information becomes available, this report will be supplemented.

 
Event Description

Olympus inspected the device at the service department of olympus (b)(4) (oaz) and found that the the examination lamp of the device was not lit up. There was no report of patient injury associated with this event.

 
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 Key11025015
MDR Text Key227148840
Report Number8010047-2020-10523
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCLK-4
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/13/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/19/2021
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-