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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HALOGEN LIGHT SOURCE
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OLYMPUS MEDICAL SYSTEMS CORP. HALOGEN LIGHT SOURCE Back to Search Results
Model Number CLK-4
Device Problems Mechanical Problem (1384); Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/08/2021
Event Type  malfunction  
Manufacturer Narrative
At this time, it does not appear the device will be returned.However, should additional information become available prior to the conclusion of the investigation, a supplemental report will be provided.
 
Event Description
It was reported, the halogen light source would not power on.There was no patient harm or consequence reported as a result of this event.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.It is assumed that the device in question is more than 10 years from manufacturing, and the switch has broken down due to long-term use.It is considered that the power was not turned on due to a failure of the power switch.Olympus will continue to monitor the field performance of this device.
 
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Brand Name
HALOGEN LIGHT SOURCE
Type of Device
HALOGEN LIGHT SOURCE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key11411577
MDR Text Key234772138
Report Number8010047-2021-03308
Device Sequence Number1
Product Code FAJ
UDI-Device Identifier04953170024511
UDI-Public04953170024511
Combination Product (y/n)N
PMA/PMN Number
K993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
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? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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