EVIS EXERA II COLONOVIDEOSCOPE PCF-H180AL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-31 for EVIS EXERA II COLONOVIDEOSCOPE PCF-H180AL manufactured by Olympus Medical Systems Corp..

MAUDE Entry Details

Report Number8010047-2020-01907
MDR Report Key9908073
Report SourceOTHER,USER FACILITY
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-06
Date Added to Maude2020-03-31
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 NameEVIS EXERA II COLONOVIDEOSCOPE
Generic NameCOLONOVIDEOSCOPE
Product CodeFDF
Date Received2020-03-31
Returned To Mfg2020-03-18
Model NumberPCF-H180AL
Device AvailabilityR
Device Eval'ed by MfgrN
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 2020-03-31

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