MAUDE MDR 4325929

MDR report key
4325929
Report number
1226420-2014-00120
Event key
0
Event type
3
Date of event
2014-11-14
Date received
2014-12-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KAYLEE BOISVERT
Address
180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US
Phone
603-603-6038
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PLASMABLADE 3.0ELECTROSURGICAL DEVICEMEDTRONIC ADVANCED ENERGY, LLCDWGPS210-030SPS210-030SUNKNOWNN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-12-120

Event Narratives#

D

Patient 1

A FEW MINUTES INTO THE CASE, AFTER THE CUSTOMER STOPPED DEPRESSING THE COAG BUTTON, THE GENERATOR STILL SHOWED AS ACTIVE AND STILL GAVE THE COAG TONE, HOWEVER, THE HAND PIECE WASN?T ACTIVE (THERE WAS NO RF ENERGY GOING TO THE HAND PIECE). THE GENERATOR WAS RESTARTED AND THE ISSUE WAS RESOLVED. APPROXIMATELY 10 MINUTES LATER, WHILE BEING USED ON COAG, THE GENERATOR STOPPED SHOWING AS ACTIVE, THERE WAS NO ACTIVATION TONE AND THE SCREEN DID NOT INDICATED COAG AS ACTIVE. THIS OCCURRED ALTHOUGH THE CUSTOMER WAS CONTINUING TO DEPRESS THE COAG BUTTON ON THE HAND PIECE AND THE HAND PIECE ITSELF WAS STILL COAGULATING AND STILL HAD RF ENERGY GOING TO IT. THE ISSUE WAS RESOLVED WHEN THE CUSTOMER STOPPED DEPRESSING COAG ON THE HAND PIECE. APPROXIMATELY 15 MINUTES LATER, AFTER A SUBSEQUENT ACTIVATION ON COAG, WHEN THE CUSTOMER STOPPED DEPRESSING THE COAG BUTTON, THE GENERATOR STILL SHOWED AS ACTIVE AND STILL GAVE THE COAG TONE, HOWEVER, THE HAND PIECE WASN?T ACTIVE AND THERE WAS NO RF ENERGY GOING TO THE HAND PIECE. A DIFFERENT GENERATOR WAS BROUGHT IN AND USED WITH THE SAME HAND PIECE TO SUCCESSFULLY COMPLETE THE CASE. CUT WAS NOT AFFECTED.

N

Patient 1

(B)(4). METHOD, RESULTS: FACILITY DISPOSED OF DEVICE. DEVICE IS NOT AVAILABLE FOR RETURN AND INSPECTION. PRODUCT EVENT: (B)(4).

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.