FDA.reportPublic FDA data

MAUDE MDR 3919515

MDR report key
3919515
Report number
1226420-2014-00043
Event key
0
Event type
3
Date of event
2014-06-06
Date received
2014-07-08
Adverse event
0
Product problem
1
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GENERATOR PULSAR REFURBISHEDGENERATOR,ELECTROSURGICAL,COAGULATION,CANCERMEDTRONIC ADVANCED ENERGY, LLCMULPS100-100RFPS100-100RFY R
308293GENERATOR PULSAR REFURBISHEDGENERATOR,ELECTROSURGICAL,COAGULATION,CANCERMEDTRONIC ADVANCED ENERGY, LLCMULPS100-100RFPS100-100RFR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-07-080

Event Narratives#

N

Patient 1

(B)(4). EVALUATION PROCESS: UNIT RECEIVED IN STANDARD SHIPPING BOX, IN GOOD CONDITION. NO POWER CORD, USER MANUAL, OR HANDPIECES WERE RECEIVED WITH THE UNIT. INTERNAL VISUAL INSPECTION FOUND NOTHING MISSING OR BROKEN IN UNIT. HANDPIECE FUNCTIONALITY WAS FAULTY; CUT BUTTON WOULD NOT OPERATE GENERATOR. COAG BUTTON WOULD ACTIVATE GENERATOR BUT ENERGY DELIVERY WOULD NOT SHUT OFF WHEN BUTTON RELEASED. WHEN USING THE FOOTSWITCH INSTEAD OF THE HANDPIECE FOR ACTIVATION THE UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. TROUBLESHOOTING REVEALED THAT COMPONENT C154 ON THE RF AMP PCBA HAS A FAULTY SOLDER JOINT: THE COAG BUTTON SIGNAL VOLTAGE COULD BE FORCED TO SWITCH BETWEEN ITS EXPECTED (UNACTIVATED) VALUE TO ABOUT HALF OF ITS EXPECTED VALUE BY FLEXING THE RF AMP PCBA. WHEN THE SIGNAL WAS AT ITS HALF-VOLTAGE VALUE, CUT BUTTON CLOSURES WERE FOUND TO BE IGNORED. COAG BUTTON CLOSURES WERE FOUND TO CAUSE THE SIGNAL TO DROP TO ITS FULLY-CLOSED VALUE (THEREBY ACTIVATING COAG OUTPUT). RELEASING THE COAG BUTTON CAUSED THE SIGNAL TO RISE BACK TO THE HALF-VOLTAGE VALUE, WHICH WAS NOT RECOGNIZED AS A BUTTON RELEASE. REMOVING THE OLD SOLDER FROM C154, CLEANING THE PADS, AND THEN RESOLDERING THE PART RESOLVED THE ISSUE. ROOT CAUSE: FAULTY SOLDER CONNECTION OF CAPACITOR C154 ON THE RF AMP PCBA CAUSED THE DESCRIBED BEHAVIOR. THIS BEHAVIOR WAS SPURIOUS; THE PROBLEM COULD BE MADE TO APPEAR/DISAPPEAR BY FLEXING THE PCB. (B)(4).

D

Patient 1

NO SURGERY INVOLVED (OUTSIDE SURGICAL ENVIRONMENT) INITIALLY REPORTED THAT THE GENERATOR FAILED TO INITIALIZE, BUT VIA ADDITIONAL INFORMATION OBTAINED THE GENERATOR TURNS ON, SCREEN LIGHTS UP, AND UNIT COMPLETES ITS SELF-TEST SUCCESSFULLY. A TEST HANDPIECE WOULD NOT CUT WHEN ACTIVATED AND THE GENERATOR DID NOT SHOW CUT MODE AS ACTIVE. INSTEAD, COAG MODE WOULD ACTIVATE AND WOULD NOT STOP SHOWING AS ACTIVE ON THE GENERATOR WHEN THE HANDPIECE ACTIVATION BUTTON WAS RELEASED AND RF ENERGY CONTINUED TO BE DELIVERED FROM THE SYSTEM (GENERATOR AND DEVICE). UNIT HAD TO BE RESTARTED FOR COAG TO STOP SHOWING AS ACTIVE ON THE GENERATOR.