FDA.reportPublic FDA data

MAUDE MDR 846393

MDR report key
846393
Report number
2431026-2007-00007
Event key
0
Event type
3
Date of event
2007-04-04
Date received
2007-05-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
KENT JONES
Address
5160 HABIENDA DRIVE DUBLIN CA 97568 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OPMI PENTERO/STAND PENTEROSURGICAL MICROSCOPECARL ZEISS SURGICAL GMBHEPT*000000-1290-983*NYN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-05-0401. O

Event Narratives#

D

Patient 1

A PT RECEIVED A BURN TO THE SKIN AROUND THE INCISION SITE WHILE UNDERGOING A LUMBER SURGICAL PROCEDURE IN THE L4-L5 AREA OF THE SPINE. DURING THE SURGERY, THE MICROSCOPE WAS SET AT A SHORT WORKING DISTANCE IN ORDER TO ILLUMINATE THROUGH THE CANNULA DIAMETER (APPROXIMATELY 19MM) AND THE LIGHT INTENSITY WAS SET AT 100%.

N

Patient 1

THE SYSTEM AND THE MICROSCOPE LIGHT SOURCE WERE INSPECTED BY A SERVICE TECHNICIAN AND FOUND TO BE OPERATING WITHIN NORMAL TOLERANCES. THE PRODUCT LABELING PROVIDEN INFO REGARDING PHOTOTOXIC TISSUE INJURY RECOMMENDING AMONG OTHER THINGS, USE OF THE LOWEST LIGHT SETTING POSSIBLE, REDUCING THE EXPOSURE TIME TO MINIMUM AND TAKING PRECAUTIONS TO COOL THE SURGICAL FIELD.