FDA.reportPublic FDA data

MAUDE MDR 497430

MDR report key
497430
Report number
9610614-2003-00010
Event key
0
Event type
3
Date of event
2003-10-23
Date received
2003-11-20
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
1ERBE APC 300ARGON PLASMA COAGULATORERBE ELEKTROMEDIZIN GMBHGEIAPC 30010132-011*K963189NYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-11-2001. H

Event Narratives#

D

Patient 1

THE ACCOUNT REPORTED THAT THE EQUIPMENT I.E., ERBE SYSTEM; ARGON PLASMA COAGULATOR (APC) MODEL APC 300 WITH AN ELECTROSURGICAL GENERATOR MODEL ICC 200 E/A WAS USED DURING A COLONOSCOPY TO TREAT MULTIPLE ARTERIOVENOUS MALFORMATIONS (AVMS). THE PROCEDURE WAS EASY, IT WENT WELL, AND THERE WERE NO COMPLICATIONS. HOWEVER, THE PATIENT RETURNED THE NEXT DAY WITH ABDOMINAL PAIN IN THE RIGHT LOWER QUADRANT. CLINICAL HISTORY AND FURTHER TESTS INDICATED THAT THERE WAS A PERFORATION IN THE ABDOMINAL AREA. THEREFORE THE PATIENT WAS TREATED WITH IV ANTIBOTICS. PT HAD AN UNEVENTFUL RECOVERY AND WAS DISCHARGED FIVE DAYS LATER.