CHANNEL NEUROENDOSCOPE, 30K, 2MM, SHORT, HIGH RESOLUTION 2233-005

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-24 for CHANNEL NEUROENDOSCOPE, 30K, 2MM, SHORT, HIGH RESOLUTION 2233-005 manufactured by Medtronic Neurosurgery.

MAUDE Entry Details

Report Number2021898-2019-00252
MDR Report Key8729342
Report SourceHEALTH PROFESSIONAL
Date Received2019-06-24
Date of Report2019-08-05
Date of Event2019-06-12
Date Mfgr Received2019-07-16
Device Manufacturer Date2018-01-17
Date Added to Maude2019-06-24
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 ContactSTACY RUEMPING
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635260594
Manufacturer G1MEDTRONIC NEUROSURGERY
Manufacturer Street125 CREMONA DRIVE
Manufacturer CityGOLETA CA 93117
Manufacturer CountryUS
Manufacturer Postal Code93117
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHANNEL NEUROENDOSCOPE, 30K, 2MM, SHORT, HIGH RESOLUTION
Generic NameENDOSCOPE, NEUROLOGICAL
Product CodeGWG
Date Received2019-06-24
Returned To Mfg2019-07-03
Model Number2233-005
Catalog Number2233-005
Lot NumberE41661
Device Expiration Date2019-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NEUROSURGERY
Manufacturer Address125 CREMONA DRIVE GOLETA CA 93117 US 93117


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-24

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