RESECTION SHEATH, 24 FR., INTERMITTENT IRRIGATION A22014A

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 2019-11-04 for RESECTION SHEATH, 24 FR., INTERMITTENT IRRIGATION A22014A manufactured by Olympus Winter & Ibe Gmbh.

MAUDE Entry Details

Report Number9610773-2019-00154
MDR Report Key9271276
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-11-04
Date of Report2019-11-15
Date Mfgr Received2019-11-14
Date Added to Maude2019-11-04
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. DANIEL WLADOW
Manufacturer StreetKUEHNSTRASSE 61
Manufacturer CityHAMBURG 22045
Manufacturer CountryGM
Manufacturer Postal22045
Manufacturer Phone4940669662
Manufacturer G1OLYMPUS WINTER & IBE GMBH
Manufacturer StreetKUEHNSTRASSE 61
Manufacturer CityHAMBURG
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRESECTION SHEATH, 24 FR., INTERMITTENT IRRIGATION
Generic NameRESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
Product CodeFJL
Date Received2019-11-04
Returned To Mfg2019-11-07
Model NumberA22014A
Catalog NumberA22014A
Lot NumberUNKNOWN
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 2019-11-04

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