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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 Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/02/2020
Event Type  Malfunction  
Manufacturer Narrative

The subject device was not returned to the service center for evaluation. The original equipment manufacturer (oem) was unable to conduct a device history record review because the serial number was unknown or manufactured more than 15 years ago. Although no device was returned, an investigation was performed by the oem. From the fact that the heat sink was burnt at the time of lamp replacement, it is inferred that internal dust and the like accumulated on the terminal at the tip of the heat sink and short-circuited due to the effect of the dust and the like, and the internal temperatures rose and the fuses were blown. The thermal fuse is non-return type, and lamp and fan do not operate when the thermal fuse blows because the fan is no longer powered by lamp. Or it was blown because the internal temperature rose due to a fan failure. An accidental failure of the thermal fuse is assumed. As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: do not apply excessive force to the light source and/or other instruments connected. Otherwise, damage and/or malfunction can the light source ventilation grill and openings should be clear of ancillary equipment. Blockage can cause overheating and equipment damage.

 
Event Description

The biomedical engineer at the user facility reported that the lamp to the halogen light source went out. Prior to any procedure the biomedical engineer observed that the end of the heat sink was burnt. The lamp was replace; the light source turns on but the lamp nor fan activates. No patient injury or harm was reported.

 
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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 Key11026711
MDR Text Key222104236
Report Number8010047-2020-10557
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation BIOMEDICAL ENGINEER
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 Received12/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberCLK-4
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/22/2020
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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