FDA.reportPublic FDA data

MAUDE MDR 348778

MDR report key
348778
Report number
9610614-2001-00009
Event key
0
Event type
3
Date of event
2001-07-27
Date received
2001-08-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
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 EELECTROSURGICAL GENERATORERBE ELEKTROMEDIZIN GMBHGEIICC 200 E10128-204*K933157NYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-08-2401. L; 2. R

Event Narratives#

D

Patient 1

A CUSTOMER REPORTED THAT DURING A POLYP REMOVAL IN THE CECUM OF A PT USING AN ELECTROSURGICAL GENERATOR (ESU), THE WALL PERFORATED. THE PT REQUIRED SURGERY TO CONTROL THE BLEEDING AND WAS IN STABLE CONDITION AFTER THE OPERATION. THE ESU SETTINGS WERE ENDOCUT, 200 WATTS AND SOFT COAG, 60 WATTS.