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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA PRO XENON LIGHT SOURCE

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OLYMPUS MEDICAL SYSTEMS CORP. VISERA PRO XENON LIGHT SOURCE Back to Search Results
Model Number CLV-S40PRO
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus repair center for evaluation. The evaluation of the device confirmed the followings; defect of the diaphragm to adjust the brightness was noted. The reported event was caused by the defect. A malfunction was noted in which the led of the power switch flashed. If additional information becomes available, this report will be supplemented.
 
Event Description
Brightness adjustment did not work. The event was found during inspection by olympus repair center. There was no report of patient injury associated with this event.
 
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Brand NameVISERA PRO XENON LIGHT SOURCE
Type of DeviceXENON 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 Key10738370
MDR Text Key224676220
Report Number8010047-2020-08165
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLV-S40PRO
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2009
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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