INNER SHEATH, FOR 26 FR. OUTER SHEATH A22040A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-10 for INNER SHEATH, FOR 26 FR. OUTER SHEATH A22040A manufactured by Olympus Winter & Ibe Gmbh.

MAUDE Entry Details

Report Number9610773-2020-00088
MDR Report Key9811852
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-10
Date of Report2020-03-20
Date of Event2020-01-02
Date Mfgr Received2020-03-19
Device Manufacturer Date2015-07-01
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
Manufacturer ContactMR. DANIEL WLADOW
Manufacturer StreetKUEHNSTRASSE 61
Manufacturer CityHAMBURG 22045
Manufacturer CountryGM
Manufacturer Postal22045
Manufacturer Phone4940669662
Manufacturer G1OLYMPUS
Manufacturer StreetKUEHNSTRASSE
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINNER SHEATH, FOR 26 FR. OUTER SHEATH
Generic NameRESECTION?SHEATHS,?IRRIGATION?RINGS,?CYSTOSCOPE?SHEATHS,?HYSTEROSCOPE?SHEATHS
Product CodeFJL
Date Received2020-03-10
Returned To Mfg2020-03-10
Model NumberA22040A
Catalog NumberA22040A
Lot Number157W
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS WINTER & IBE GMBH
Manufacturer AddressKUEHNSTRASSE 61 HAMBURG 22045 GM 22045


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-10

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