AQUAMANTYS GENERATOR 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 report with the FDA on 2014-01-07 for AQUAMANTYS GENERATOR 40-402-1 manufactured by Medtronic Advanced Energy, Llc.

Event Text Entries

[4055094] Discovered during the end of a breast oncology (sentinel node/axillary dissection) procedure that patient had a burn to their arm. Burn likely attributed to saline run off during device utilization, specifically that the hot saline ran along the retractors and pooled on the patient's arm resulting in a burn. Patient burn treated with topical measures. Facility is unsure which generator was in use at the time of the incident, therefore, it cannot be confirmed which generator the issue occurred with. All generators will be returned for investigation.
Patient Sequence No: 1, Text Type: D, B5


[11495657] (b)(4). Method, results and conclusion: product received by manufacturer and pending inspection. Product event: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1226420-2014-00004
MDR Report Key3558876
Report Source06,07
Date Received2014-01-07
Date of Report2013-12-16
Date of Event2013-12-13
Date Mfgr Received2013-12-16
Date Added to Maude2014-04-08
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 FDA0
Event Location0
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 NameAQUAMANTYS GENERATOR
Generic NameGENERATOR,ELECTROSURGICAL,COAGULATION,CANCER
Product CodeMUL
Date Received2014-01-07
Returned To Mfg2014-01-06
Model Number40-402-1
Catalog Number40-402-1
Device AvailabilityR
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 2014-01-07

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