EVIS EXERA BRONCHOVIDEOSCOPE BF-160

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for EVIS EXERA BRONCHOVIDEOSCOPE BF-160 manufactured by Olympus Medical Systems Corp..

MAUDE Entry Details

Report Number2951238-2020-00365
MDR Report Key9813091
Date Received2020-03-10
Date of Report2020-03-10
Date of Event2020-02-21
Date Facility Aware2020-02-24
Report Date2020-02-24
Date Reported to Mfgr2020-02-24
Date Added to Maude2020-03-10
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEVIS EXERA BRONCHOVIDEOSCOPE
Generic NameBRONCHOVIDEOSCOPE
Product CodeEOQ
Date Received2020-03-10
Model NumberBF-160
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
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
101. Other 2020-03-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.