FDA.reportPublic FDA data

MAUDE MDR 480334

MDR report key
480334
Report number
9610614-2003-00007
Event key
0
Event type
3
Date of event
2003-07-28
Date received
2003-08-25
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 2ARGON PASMA COAGULATORERBE ELEKTROMEDIZIN GMBHGEIAPC 210134-000*K024047NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-08-2501. H; 2. L; 3. R

Event Narratives#

D

Patient 1

THE ACCOUNT REPORTED THAT DURING A COLONOSCOPY TO REMOVE MULTIPLE ARTERIVENOUS MALFORMATIONS (AVMS) WITH THE EQUIPMENT [I.E., ERBE SYSTEM; ARGON PLASMA COAGULATOR (APC) MODEL APC 2 WITH AN ELECTROSURGICAL GENERATOR MODEL VIO 300 D (P.N.: 10140-000)], A PT'S COLON WALL WAS PERFORATED [NOTE: MULTIPLE AVMS WERE SUCCESSFULLY TREATED IN AN UPPER G.I. (EGD) PRIOR TO THE COLONOSCOPY.}. THE MODE WAS PULSED ARGON AT EFFECT 1 WITH 20 WATTS FOR TREATING THE AVMS IN THE CECUM. NO PROBLEMS WERE EVIDENT WITH THE PT AFTER THE PROCEDURES. HOWEVER, THE PT RETURNED THE NEXT DAY AND A PERFORATION WAS DISCOVERED WHICH REQUIRED SURGERY TO REPAIR THE BOWEL. THE PT THEN DEVELOPED PERITIONITIS.