MAUDE MDR 4212430

MDR report key: 4212430
Report number: 1226420-2014-00105
Event key: 0
Event type: 3
Date of event: 2014-10-01
Date received: 2014-10-30
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 0

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
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	MAE UNKNOWN PEAK PULSAR GENERATOR	GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER	MEDTRONIC ADVANCED ENERGY, LLC	MUL	MAE UNK PEAK GEN	MAE UNK PEAK GEN					*	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2014-10-30	0

Event Narratives#

D

Patient 1

DURING A CASE, THE SURGEON REPORTED THAT THERE WAS REVERSED ACTIVATION ON THE PULSAR GENERATOR, SPECIFICALLY WHEN THE CUT BUTTON IS PRESSED, THE GENERATOR SHOWS COAG MODE IS ACTIVATED AND WHEN THE COAG IS PRESSED, THE GENERATOR SHOWS CUT MODE IS ACTIVATED. NO PATIENT IMPACT, PATIENT INFORMATION UNAVAILABLE.

N