EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-04 for EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F manufactured by Olympus Medical Systems Corp..

Event Text Entries

[104809542] The subject device in this report has not yet been returned to omsc for evaluation. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available or if the device is returned at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10


[104809543] Olympus medical systems corp. (omsc) was informed that during two surveillance culturing tests conducted by the user facility, following microbes were detected from the subject device. [first time]. - instrument channel: unspecified microbes (1 cfu / 20ml). [second time]. - instrument channel: corynebacterium species (1 cfu /20ml). Other detailed information such as the reprocessing method was not provided. There was no report of infection associated with this report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010047-2018-00575
MDR Report Key7395034
Date Received2018-04-04
Date of Report2018-04-26
Date Mfgr Received2018-04-05
Device Manufacturer Date2016-12-09
Date Added to Maude2018-04-04
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
Manufacturer CountryUS
Manufacturer Phone426425177
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
Generic NameULTRASONIC BRONCHOFIBERVIDEOSCOPE
Product CodePSV
Date Received2018-04-04
Model NumberBF-UC180F
ID Number04953170356360
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 2018-04-04

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