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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 Problem Failure to Power Up (1476)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to olympus medical systems corp. (omsc), therefore omsc cannot investigate the device. The exact cause of the reported event could not be conclusively determined. Aging deterioration may have caused the defect because 24 years have passed since the device was manufactured. If additional information becomes available, this report will be supplemented.
 
Event Description
The user pressed the power button, but it didn't respond. The user couldn't turn on the device. The button responded only while the user was pressing the top cover of the device. The device reacted only when the device presses the top cover.
 
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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 Key11073396
MDR Text Key228027235
Report Number8010047-2020-10999
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 12/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/25/2020
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? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/04/2020
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 Reuse

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