HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12? AND 30?, STERILE, SINGLE USE A22251C

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 2019-10-25 for HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12? AND 30?, STERILE, SINGLE USE A22251C manufactured by Olympus Winter & Ibe Gmbh.

MAUDE Entry Details

Report Number9610773-2019-00146
MDR Report Key9236951
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-10-25
Date of Report2019-10-28
Date of Event2019-10-15
Date Mfgr Received2019-10-25
Device Manufacturer Date2018-08-30
Date Added to Maude2019-10-25
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 MEDICAL PRODUCTS CZECH, SPOL. S R.O.
Manufacturer StreetTELICKOVA 457/29
Manufacturer CityPREROV 75124
Manufacturer CountryEZ
Manufacturer Postal Code75124
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12? AND 30?, STERILE, SINGLE USE
Generic NameHF-RESECTION ELECTRODES
Product CodeFAS
Date Received2019-10-25
Model NumberA22251C
Catalog NumberA22251C
Lot Number1000030183
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS WINTER & IBE GMBH
Manufacturer AddressKUEHNSTRASSE 61 HAMBURG 22045 GM 22045


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-25

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