FDA.reportPublic FDA data

MAUDE MDR 497992

MDR report key
497992
Report number
9610614-2003-00011
Event key
0
Event type
3
Date of event
2003-10-27
Date received
2003-11-19
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 PLASMA COAGULATORERBE ELEKTROMEDIZIN GMBHGEIAPC 210134-000*K024047NYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-11-1901. L

Event Narratives#

D

Patient 1

A SALES REPRESENTATIVE REPORTED THAT DURING A BRONCHOSOPY FOR PAPILOMATOSIS WITH THE EPUIPMENT [I.E., ERBE SYSTEM; ARGON PLASMA COGULATOR (APC) MODEL APC 2 WITH AN ELECTROSURGICAL GENERATOR MODEL VIO 300 D) AN AIRWAY FIRE OCCURRED. THE DOCTOR IMMEDIATELY REMOVED THE SCOPE AND FLUSHED WITH SYRINGES OF SALINE. THE BENDING RUBBER OF THE BRONCHOSCOPE AND TMA TUBE WERE FOUND TO HAVE MELTED. THERE WAS NO REPORT THAT THE PT WAS INJURED OR ON THE PT'S CONDITION.