• 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 Device Fell (4014)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation and the repair center confirmed the complaint. The device was repaired and returned to the customer. Based on the results of the investigation, the device stopped working to damage of either the electrical circuit, the mechanical structure, or both of them because the user dropped it.
 
Event Description
The customer notified olympus that the device was dropped, it broke and no longer works. There was no report of patient involvement.
 
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 Key11178101
MDR Text Key227134571
Report Number8010047-2021-01479
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 01/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLK-4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/09/2020
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

-
-