EVIS LUCERA ELITE XENON LIGHT SOURCE CLV-290SL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for EVIS LUCERA ELITE XENON LIGHT SOURCE CLV-290SL manufactured by Olympus Medical Systems Corp..

Event Text Entries

[118557881] The subject clv-290sl was not returned to olympus medical systems corp. (omsc). The user will not return the subject clv-290sl. The clv-290sl instruction manual states the corresponding method when there is an abnormality for the device. There were no further details provided. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10


[118557882] The user used the subject clv-290sl and the unspecified monitor in the unspecified procedure. During the procedure, the color of the image displayed on the monitor turned green. The user replaced the subject clv-290sl with the similar device and completed the procedure. There was no report of the patient's injury regarding this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010047-2018-01650
MDR Report Key7817455
Date Received2018-08-27
Date of Report2018-11-26
Date of Event2018-08-10
Date Mfgr Received2018-11-08
Date Added to Maude2018-08-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR KAZUTAKA MATSUMOTO
Manufacturer Street2951 ISHIKAWA-CHO
Manufacturer CityHACHIOJI-SHI, TOKYO-TO 192-8507
Manufacturer CountryJA
Manufacturer Postal192-8507
Manufacturer Phone426425177
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEVIS LUCERA ELITE XENON LIGHT SOURCE
Generic NameXENON LIGHT SOURCE
Product CodeGCT
Date Received2018-08-27
Model NumberCLV-290SL
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-27

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