EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE SIF-Q180

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-22 for EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE SIF-Q180 manufactured by Olympus Medical Systems Corp..

MAUDE Entry Details

Report Number8010047-2019-02996
MDR Report Key8919658
Date Received2019-08-22
Date of Report2019-09-25
Date Mfgr Received2019-09-04
Device Manufacturer Date2008-01-22
Date Added to Maude2019-08-22
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 Report0

Device Details

Brand NameEVIS EXERA II SMALL INTESTINAL VIDEOSCOPE
Generic NameSMALL INTESTINAL VIDEOSCOPE
Product CodeFDA
Date Received2019-08-22
Model NumberSIF-Q180
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 192-8507 JA 192-8507


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-22

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