FDA.reportPublic FDA data

MAUDE MDR 6299624

MDR report key
6299624
Report number
9610614-2017-00003
Event key
0
Event type
3
Date of event
2017-01-06
Date received
2017-02-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JOHN TARTAL
Address
2225 NORTHWEST PARKWAY MARIETTA GA 30067 US
Phone
770-770-7709
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ERBE APC 2ARGON PLASMA COAGULATORERBE ELEKTROMEDIZIN GMBHGEIAPC 210134-000Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-0301. R

Event Narratives#

N

Patient 1

THE ARGON PLASMA COAGULATOR (APC)/ELECTROSURGICAL UNIT (ESU) SYSTEM WAS RETURNED AND THOROUGHLY EVALUATED. THE FINDINGS WERE AS FOLLOWS: CHRONOLOGICAL LOG REVIEW: THE LOG ON THE DAY OF THE REPORTED EVENT WAS REVIEWED. NO SYSTEM ISSUES WERE RECORDED. APC/ESU INSPECTION AND TESTING: A TECHNICAL SAFETY CHECK WAS PERFORMED ON EACH UNIT. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALSO, THE GAS FLOW RATES WERE MEASURED AND FOUND TO BE WITHIN THEIR ACCEPTABLE RANGES FOR THE APC. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS ON BOTH DEVICES. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) FOR THE APC AND ESU. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE SITUATION, ADDITIONAL CASE WORK IS BEING PLANNED WITH THE DOCTOR. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

D

Patient 1

IT WAS REPORTED THAT AN ERBE SYSTEM, ARGON PLASMA COAGULATOR (APC) MODEL APC 2 WITH AN ELECTROSURGICAL UNIT (ESU/GENERATOR) SYSTEM [PART NUMBER (P/N) 10140-100, SERIAL NUMBER (S/N) (B)(4))] WAS INVOLVED IN A PATIENT INCIDENT. THE EQUIPMENT WAS USED TO REMOVE A POLYP. DEFAULT SETTINGS WERE USED, BUT CAUTERY DID NOT FUNCTION PROPERLY. AFTER THE PROCEDURE, SURGICAL INTERVENTION WORK WAS DONE. NO FURTHER INFORMATION WAS PROVIDED ON THE REASON FOR THE SECOND PROCEDURE OR THE PATIENT'S CONDITION.