FDA.reportPublic FDA data

MAUDE MDR 3674409

MDR report key
3674409
Report number
1319211-2014-00018
Event key
0
Event type
3
Date of event
2014-02-07
Date received
2014-03-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
DAN ANDERSON
Address
603 QUEENSBURY AVE. QUEENSBURY NY 12804 US
Phone
508-508-5087
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RITA MODEL 1500XMODEL 1500X ELECTROSURGICAL RF GENERATORANGIODYNAMICSGEI700-101731R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-03-0401. R

Event Narratives#

D

Patient 1

AS REPORTED (B)(4) 2014, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN RFA PROCEDURE OF THE LIVER. DURING THE PROCEDURE, A PAD TEMP WARNING DISPLAYED. THE PROCEDURE WAS STOPPED AND THE PADS WERE REMOVED. AS THE TREATING PHYSICIAN WAS REMOVING THE THERMO PADS FROM THE PATIENT'S FLANK, SOME OF THE SKIN ADHERED TO THE PADS AS THEY WERE REMOVED. THE TREATING PHYSICIAN APPLIED ICE TO THE AFFECTED AREA. IT WAS REPORTED THE PATIENT WAS STABLE POST PROCEDURE. IT WAS REPORTED THE RFA SYSTEM IS AVAILABLE FOR RETURN FOR EVALUATION BY THE MFR.

N

Patient 1

IT WAS REPORTED THAT THE RFA SYSTEM INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MFR FOR EVALUATION. TO DATE THE UNIT HAS YET TO BE RETURNED. ATTEMPTS ARE BEING MADE TO OBTAIN THE UNIT. AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS. A REVIEW OF THE HARDWARE SERVICE RECORDS FOR THE ACCOUNT'S RFA GENERATOR (S/N (B)(4)) NOTED NO ISSUES. THE RESULTS OF THE UNIT EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REF MEDWATCH REPORT # 1056436-2014-00007 FOR THERMO PADS. (B)(4).