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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 CLH-SC
Device Problems Electrical /Electronic Property Problem (1198); Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2020
Event Type  Injury  
Manufacturer Narrative

The subject device was returned to omsc for evaluation. Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. Omsc checked the subject device and found that the reported phenomenon was not duplicated. In addition, there was no abnormality in visual inspection and operation check. The exact cause of the reported event could not be conclusively determined. However, there was the possibility that this phenomenon was attributed to a temporary contact unstableness due to the exceeded inrush current when the power was turned on. If additional information becomes available, this report will be supplemented.

 
Event Description

Olympus medical systems corp. (omsc) was informed from the user that during the preparation for an unspecified procedure at the user facility, it was found that the subject device could not be turned the power on. Therefore, the intended procedure had to be cancelled and postponed. 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 Key10760154
MDR Text Key214147225
Report Number8010047-2020-08312
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2020
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCLH-SC
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/23/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/02/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/12/2019
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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