PLASMABLADE 3.0 PS210-030S

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 PLASMABLADE 3.0 PS210-030S manufactured by Medtronic Advanced Energy, Llc.

Event Text Entries

[4862925] Plasmablade device was being used on coag 6 and approximately 1 hour into a bilateral mastectomy case, it was noticed that the tip coating appeared to have melted. Another plasmablade device was opened and the case continued, but the second device had the same melting issue, which was discovered near the end of the case. Case was completed successfully with alternative medical device. The second device is being returned for investigation. The first device was discarded by the facility. This report represents product line #30-the device that was discarded.
Patient Sequence No: 1, Text Type: D, B5


[12181652] Product event: (b)(4). Method, results: facility disposed of device. Device is not available for return and inspection. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[103813132] 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 Number1226420-2014-00077
MDR Report Key4043711
Report Source06,07,COMPANY REPRESENTATIVE,
Date Received2014-08-28
Date of Report2014-08-01
Date of Event2014-07-29
Date Mfgr Received2014-08-01
Device Manufacturer Date2014-04-01
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 NamePLASMABLADE 3.0
Generic NameELECTROSURGICAL DEVICE
Product CodeDWG
Date Received2014-08-28
Model NumberPS210-030S
Catalog NumberPS210-030S
Lot NumberFL50805926
Device Expiration Date2017-04-01
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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