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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 Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus repair center, but not returned to olympus medical systems corp. (omsc). Therefore, omsc could not confirm the device. Olympus repair center could not confirm the user-reported phenomenon. Olympus repair center confirmed a broken fuse of the device. Because the device was manufactured more than 15 years ago, omsc could not confirm the device history record. Omsc surmised that this phenomenon attributed to the following. The power cable was not connected to the device. The power switch temporarily malfunctioned. The lamp was not lit up due to a blown fuse. If significant additional information is received, this report will be supplemented.
 
Event Description
During the procedure, the user found that the user could not turn on the device's power. There was no report of patient injury associated with this event. The user replaced the device with another device and completed the procedure. The device was returned to olympus repair center. Olympus repair center found that the lamp of the device was not lit up. The user facility did not provide other detailed information.
 
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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 Key12149049
MDR Text Key260948459
Report Number8010047-2021-08714
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2021
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 Manufacturer12/28/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/17/2021
Was Device Evaluated by Manufacturer? Yes
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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