FDA.reportPublic FDA data

MAUDE MDR 523135

MDR report key
523135
Report number
9610614-2004-00008
Event key
0
Event type
3
Date of event
2004-03-26
Date received
2004-04-30
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
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
1ERBOTOM ICC 200 E/AELECTROSURGICAL GENERATORERBE ELECTROMEDIZIN GMBHGEIICC 200 E/A10128-205NAK933157NYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-04-3001. L; 2. R

Event Narratives#

D

Patient 1

DURING A POLYP REMOVAL IN THE COLON, THE WALL WAS PERFORATED. THE ELECTROSURGICAL GENERATOR (ESU) WAS IN THE ENDOCUT MODE, EFFECT 3 AT 200 WATTS. THE POLYP HAD A WIDE BASE WITH LITTLE OR NO STALK. UPON ITS REMOVAL, THE COLON APPEARED TO STILL BE INTACT. HOWEVER, FREE AIR IN THE ABDOMEN WAS FOUND WHICH INDICATED THAT THE COLON WALL HAD BEEN PERFORATED. THEREFORE, THE PT UNDERWENT A LAPAROTOMY TO SUTURE THE HOLE CLOSED. THE PT IS NOW FINE.