FDA.reportPublic FDA data

MAUDE MDR 555481

MDR report key
555481
Report number
9610614-2004-00020
Event key
0
Event type
3
Date of event
2004-10-15
Date received
2004-11-16
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
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 200 EELECTROSURGICAL GENERATORERBE ELEKTROMEDIZIN GMBHGEIICC 200 E10128-204NAK933157NRY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-11-1601. L; 2. R

Event Narratives#

D

Patient 1

THE ACCOUNT REPORTED THAT DURING/UPON A POLYPECTOMY PROCEDURE, THE PATIENT'S COLON WALL WAS PERFORAED. THE SETTINGS OF THE ELECTROSURGICAL UNIT (ESU) USED FOR THE CLINICAL APPLICATION WERE NOT PROVIDED BY THE HOSPITAL. THE PT UNDERWENT SURGERY AND IS OKAY.