FDA.reportPublic FDA data

MAUDE MDR 265225

MDR report key
265225
Report number
9610614-2000-00001
Event key
0
Event type
3
Date of event
2000-02-03
Date received
2000-02-23
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
CHRISTIAN ERBE
Address
2275 NORTHWEST PKWY STE 105 MARIETTA GA 30067 US
Phone
770-770-7709
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ARGON PLASMA COAGULATORARGON PLASMA COAGULATORERBE USAGEIAPC 30010132-011NAK963189NRY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-02-2301. R

Event Narratives#

D

Patient 1

PHYSICIAN HAD A PERFORATION IN THE DUODENUM VILLOUS ADENOMA WHILE USING THE ERBE APC 300. THE APC 300 WAS SET AT A FLOW RATE OF 2.0 LITERS PER MIN (LPM) AND 50 WATTS. THE PHYSICIAN, WHO WAS USING A 45 DEGREE SCOPE, STATED THAT FIRING THE APC PROBE TANGENTIALLY TO THE TARGET TISSUE WAS DIFFICULT IN THIS PARTICULAR PROCEDURE. THEREFORE, MOST OF THE APC ACTIVATIONS WERE "EN FACE".