FDA.reportPublic FDA data

MAUDE MDR 645250

MDR report key
645250
Report number
9610614-2005-00017
Event key
0
Event type
3
Date of event
2005-06-07
Date received
2005-11-04
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
JOHN TARTAL
Address
2225 NORTHWEST PKWY 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 30010132-010NAK963189NYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-11-0401. L; 2. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING A BRONCHOSCHOPY WITH THE EQUIPMENT [I.E., ERBE SYSTEM; ARGON PLASMA COAGULATOR (APC) MODEL APC 300, WITH AN ELECTROSURGICAL UNIT (ESU/GENERATOR) MODEL ICC 200 E/A, AN AIRWAY FIRE OCCURRED. THE MONITOR WENT BLANK, THERE WAS SMOKE, AND A FLAME WAS SEEN. THE PT'S MUCOUS MEMBRANE OF THE LARYNX AND EPIGLOTTIS WAS BURNED. THE PT WAS INJECTED WITH 500 MG OF PNEDMISOLUT, TRANSFERRED TO THE ICU, AND INTUBATED. NOTE: THE EQUIPMENT WAS DISTRIBUTED BY ERBE ELECTROMEDIZIN, THE PARENT COMPANY. THE INTERNATIONAL PART NUMBER 10132-010 OF THE APC IS EQUIVALENT TO USA PART NUMBER 10132-011 WITH THE INTERNATIONAL PART NUMBER 10128-023 OF THE ESU BEING EQUIVALENT TO USA PART NUMBER 10128-205.