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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 Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2021
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 "front bezel needs to be replaced. " upon inspection and testing of the returned device by the service department, it was noted that the spare lamp was missing. This report is submitted for the malfunction of missing spare lamp. As this was found during in-house service, there was no patient involvement.
 
Manufacturer Narrative
The device was evaluated by olympus and it was determined the spare lamp was missing. 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 Key12037123
MDR Text Key280572320
Report Number8010047-2021-07789
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 user facility
Type of Report Initial,Followup
Report Date 07/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2021
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 Manufacturer05/26/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No

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