CURVED SUCTION 90 9733451 EM ENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for CURVED SUCTION 90 9733451 EM ENT manufactured by Medtronic Navigation, Inc.

Event Text Entries

[185951248] The returned curved suction was analyzed, and it was found that the weld has broken and the shaft has separated from the body. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185951249] Medtronic received information regarding a navigation system being used during a functional endoscopic sinus surgery (fess) procedure. It was reported that the curved suction was damaged at the instrument tracker interface during the case. The case was able to be completed and there was no harm to the patient. The procedure was not delayed over an hour. Additional information was received. It was reported that the cause is unknown. The instrument came apart and was unable to be used after it separated. It initially verified before it came apart.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1723170-2020-01117
MDR Report Key9905118
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-11
Date Mfgr Received2020-03-11
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 ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC NAVIGATION, INC
Manufacturer Street826 COAL CREEK CIRCLE
Manufacturer CityLOUISVILLE CO 80027
Manufacturer CountryUS
Manufacturer Postal Code80027
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCURVED SUCTION 90 9733451 EM ENT
Generic NameINSTRUMENT, STEREOTAXIC
Product CodeHAW
Date Received2020-03-31
Returned To Mfg2020-03-17
Model Number9733451
Catalog Number9733451
Lot Number18935
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NAVIGATION, INC
Manufacturer Address826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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