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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 Problems Failure to Power Up (1476); Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
A user facility returned the olympus, model clk-4, halogen light source to olympus for repair due to a report of the "video transmission is faulty. " upon inspection and testing of the returned device, it was found that the spare lamp was missing and the device would not power on. This report is submitted for the malfunctions of missing spare lamp and failure to power on. There has been no patient injury, associated with the problems, reported to olympus.
 
Manufacturer Narrative
The device was evaluated by olympus. The evaluation determined the spare lamp was missing and the power switch failed. The device could not be powered on. It was determined that the power switch and connecting cable were burnt. The investigation is ongoing and the root cause of the reported event cannot be determined at this time. If additional information becomes available, this report will be supplemented accordingly.
 
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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
MDR Report Key12651165
MDR Text Key280801816
Report Number8010047-2021-13301
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
PMA/PMN Number
K993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/22/2021
Is This a Reprocessed and Reused Single-Use Device? No

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