FDA.reportPublic FDA data

MAUDE MDR 312744

MDR report key
312744
Report number
1038548-2001-00002
Event key
0
Event type
3
Date received
2001-01-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
PETE STEGAGNO
Address
5175 SOUTH ROYAL ATLANTA DRIVE TUCKER GA 30084 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1300 WATT XENON LIGHT SOURCEENDOSCOPE, LIGHT SOURCEGENZYME BIOSURGERYGCTNA89-8350NAK962365NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-01-1901. O

Event Narratives#

D

Patient 1

THE REPORTER STATED THAT AFTER TURNING ON THE POWER, THE TEMPERATURE WENT HIGHER AND HIGHER CONTINUOUSLY AND THE SCOPE CONNECTED THROUGH THE LIGHT CABLE WAS HEATED TOO, WHICH SCALDED THE PT. THIS INCIDENT OCCURRED AT HOSPITAL. FURTHER INFORMATION WAS NOT AVAILABLE.