XENON LAMP MD-631

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for XENON LAMP MD-631 manufactured by Olympus Medical Systems Corp..

Event Text Entries

[145222643] The subject md-631 was not returned to olympus medical systems corp. (omsc) for evaluation yet. Omsc investigate the subject md-631 to determine the cause of this phenomenon when omsc receives it. 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


[145222644] During the unspecified procedure with the operation microscope ome-8000 and the xenon light ome8-slx using the xenon lamp md-631, the subject md-631 went off. The user replaced the subject md-631 with another xenon lamp to complete the procedure. There was no report of the patient injury other than replacing the device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010047-2019-01946
MDR Report Key8614656
Date Received2019-05-16
Date of Report2019-07-19
Date of Event2019-04-18
Date Mfgr Received2019-06-26
Date Added to Maude2019-05-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 Report3

Device Details

Brand NameXENON LAMP
Generic NameXENON LAMP
Product CodeGCT
Date Received2019-05-16
Model NumberMD-631
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-16

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