FDA.reportPublic FDA data

MAUDE MDR 5217102

MDR report key
5217102
Report number
9610614-2015-00012
Event key
0
Event type
3
Date of event
2015-09-24
Date received
2015-11-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
12015-11-1101. H; 2. R

Event Narratives#

N

Patient 1

THE APC/ESU SYSTEM WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. 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 (NOTE: SOME UNRELATED SERVICE WORK WAS PERFORMED ON THE APC.). 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. MOST LIKELY THERE WERE MANY FACTORS INVOLVED IN THE REPORTED EVENT. HOWEVER, IT APPEARS THAT UPON THE INTERVENTION, THE REMAINING TISSUE OF THE BOWEL WALL IN THE CECUM (A VERY THIN WALLED AREA IN THE COLON) DID NOT STAY INTACT WHICH RESULTED IN THE PERFORATION. NONETHELESS, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE 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) [PART NUMBER 10140-100, SERIAL NUMBER (B)(4)) WAS USED IN A COLONOSCOPY TO TREAT A POLYP IN THE CECUM. NO DETAILS INVOLVING THE SETTINGS WERE PROVIDED BUT THE USER REPORTED THAT THE OUTPUT POWER FROM THE APC SEEMED TO BE TOO HIGH. A PERFORATION OCCURRED AND SURGICAL INTERVENTION WAS REQUIRED TO ADDRESS THE ISSUE.