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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 Type  malfunction  
Event Description
The customer originally returned the olympus halogen light source because of a damaged handle noticed during preparation for use. Additional details relating to the patient and the event have been requested, but no response has been received at this time. There was no patient harm or consequence reported as a result of this event. During the device evaluation, it was discovered that the main lamp had a low level output and the spare lamp was missing. This report is being submitted to capture the missing lamp.
 
Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing. During the initial evaluation, the user report was confirmed. Additionally, the spare lamp from the unit was missing. If additional information becomes available following device evaluation, a supplemental report will be filed.
 
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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 Key12668545
MDR Text Key281743744
Report Number8010047-2021-13431
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2021
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 Manufacturer09/29/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2014
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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