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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, it was noted that the temperature control was damaged, the lamp holder was aging, the base was deformed and rusted, the outer shell was deformed and damaged, and the front panel was damaged.Final remarks from the evaluation team were ¿the bulb is broken, does not light up, and the rear panel is slightly deformed.¿ if additional information becomes available following the device evaluation, a supplemental report will be filed.
 
Event Description
The customer originally returned their olympus halogen light source because it was experiencing a fan malfunction during preparation for a diagnostic procedure.According to the initial reporter, the staff continued and completed the case using the subject device with a minimal delay and no patient harm.During the device evaluation, it was discovered that the lamp of the subject device had failed.This report is being submitted to capture the failing lamp.
 
Event Description
The customer originally returned their olympus halogen light source because it was experiencing a fan malfunction during preparation for a diagnostic procedure.According to the initial reporter, the staff continued and completed the case using the subject device with a minimal delay and no patient harm.During the device evaluation, it was discovered that the lamp of the subject device had failed.This report is being submitted to capture the failing lamp.
 
Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, it was noted that the temperature control was damaged, the lamp holder was aging, the base was deformed and rusted, the outer shell was deformed and damaged, and the front panel was damaged.Final remarks from the evaluation team were ¿the bulb is broken, does not light up, and the rear panel is slightly deformed.¿ if additional information becomes available following the device evaluation, a supplemental report will be filed.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the root cause of the lamp not illuminating could not be identified.However, it is likely the cause is related to a faulty lamp.Olympus will continue to monitor field performance for 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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key13120243
MDR Text Key285168480
Report Number8010047-2021-16984
Device Sequence Number1
Product Code FAJ
UDI-Device Identifier04953170024528
UDI-Public04953170024528
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer12/08/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/09/2021
Initial Date FDA Received12/30/2021
Supplement Dates Manufacturer Received03/11/2022
Supplement Dates FDA Received04/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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