FDA.reportPublic FDA data

MAUDE MDR 342482

MDR report key
342482
Report number
9610614-2001-00006
Event key
0
Event type
3
Date of event
2001-06-10
Date received
2001-07-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JOHN TARTAL
Address
2275 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 300ARGON PLASMA COAGULATOR SYSTEMERBE ELEKTROMEDIZIN GMBHGEIAPC 30010132-011*K963189NYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-07-1701. L; 2. R

Event Narratives#

D

Patient 1

AN ACCOUNT REPORTED AN ADVERSE EVENT USING THE COMPANY'S EQUIPMENT (I.E., ERBE SYSTEM; ARGON PLASMA COAGULATOR (APC) MODEL APC 300 WITH AN ELECTROSURGICAL GENERATOR W/ENDOCUT & ARGON MODEL ICC 200 E/A (P.N.: 10128-205). THE PHYSICIAN WAS ATTEMPTING TO REMOVE A LESION IN THE RECTUM. UPON ACTIVATING THE SYSTEM, A LOUD POP WAS HEARD. IMMEDIATELY PERFORATIONS WERE NOTICED. THE PATIENT UNDERWENT SURGERY TO HAVE THREE PERFORATIONS REPAIRED AND IS RECOVERING FINE.