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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/11/2020
Event Type  Malfunction  
Manufacturer Narrative

Since the subject device was not returned to olympus medical systems corp. (omsc), it could not be investigated. Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. The exact cause of the reported event could not be conclusively determined. However based on the report of olympus india, omsc surmised there was the possibility this phenomenon was attributed to the temperature fuse failure of the subject device due to the accidental failure or fuse blown by overheating because it was used a non-resettable fuse. The fuse blown might have occurred because the subject device was used in an environment with poor intake and exhaust conditions, such as other equipment being placed at the intake and exhaust ports by the user. If additional information becomes available, this report will be supplemented.

 
Event Description

Olympus medical systems corp. (omsc) was informed that the temperature fuse of the subject device was not worked during the incoming inspection for the repair at olympus india. There was no report of patient injury associated with this event.

 
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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 Key11009218
MDR Text Key221560706
Report Number8010047-2020-10343
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/26/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/15/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCLK-4
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/22/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/22/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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