FDA Adverse Event Malfunction Summary report: N

PULSAR GENERATOR

MDR report key: 2821440 · Received October 25, 2012

Report

Report Number: 3007069406-2012-00307
Event Type: Malfunction
Date Received: October 25, 2012
Date of Event: March 7, 2011
Report Date: March 7, 2011
Manufacturer: MEDTRONIC ADVANCED ENERGY LLC
Product Code: GEI
PMA / PMN Number: K082786
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MFR FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. THE PULSAR GENERATOR WAS RECEIVED IN POOR CONDITION WITH DARK AND SCRATCHES ON THE UPPER LID. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THE F6 FAULT INDICATES A TEMPORARY LOSS OF COMMUNICATION BETWEEN THE UCB AND RF CONTROLLER. THE HIGH VOLTAGE POWER SUPPLY TO RF AMPLIFIER WIRE HARNESS WAS FOUND TO BE ROUTED TOO CLOSE TO THE WIRE HARNESS CONNECTING THE RF CONTROLLER TO UCB. CORRECTION OF THE WIRE ROUTE REDUCES THE NOISE COUPLING BETWEEN THE TWO HARNESSES. THE MONOPOLAR CONNECTOR WAS REPLACED. APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE. END OF REPORT.

Description of Event or Problem · 1

IT WAS REPORTED DURING A BREAST BIOPSY, THE DEVICE DISPLAYED A FAULT CODE. THE HANDPIECE WAS CHANGED OUT AND THE CASE RESUMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PULSAR GENERATOR		GEI	MEDTRONIC ADVANCED ENERGY LLC	PULSAR GENERATOR	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI			PLASMABLADE