GENERATOR AQM 115V 40-402-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2014-08-28 for GENERATOR AQM 115V 40-402-1 manufactured by Medtronic Advanced Energy, Llc.

Event Text Entries

[4908686] Surgeon reports he is no longer using aquamantys as he had two patients present with an unknown infection after use of the aquamantys 6. 0. The issue happened over a year ago, but was first reported to medtronic 8/4/2014. No further information available regarding case details or patient demographics. The patient infections have healed and patients are reported to be doing fine now with no further impact. Due to lack of detailed patient information, both cases are being reported via this one mdr report.
Patient Sequence No: 1, Text Type: D, B5


[12278245] Product event: (b)(4). Method,results,conclusion: generator still in use and facility not returning for investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[103813264] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1226420-2014-00080
MDR Report Key4043716
Report Source06,07,COMPANY REPRESENTATIVE,
Date Received2014-08-28
Date of Report2014-08-04
Date of Event2014-08-04
Date Mfgr Received2014-08-04
Date Added to Maude2014-09-12
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 ContactKAYLEE BOISVERT
Manufacturer Street180 INTERNATIONAL DRIVE
Manufacturer CityPORTSMOUTH NH 03801
Manufacturer CountryUS
Manufacturer Postal03801
Manufacturer Phone6038426234
Manufacturer G1MEDTRONIC ADVANCED ENERGY, LLC
Manufacturer Street180 INTERNATIONAL DRIVE
Manufacturer CityPORTSMOUTH NH 03801
Manufacturer CountryUS
Manufacturer Postal Code03801
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGENERATOR AQM 115V
Generic NameGENERATOR,ELECTROSURGICAL,COAGULATION,CANCER
Product CodeMUL
Date Received2014-08-28
Model Number40-402-1
Catalog Number40-402-1
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC ADVANCED ENERGY, LLC
Manufacturer Address180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-28

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