FDA.reportPublic FDA data

MAUDE MDR 859125

MDR report key
859125
Report number
2431026-2007-00009
Event key
0
Event type
3
Date of event
2007-02-01
Date received
2007-06-04
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
22 CARL ZEISS STRASSE OBERKOCHEN D-734 GM
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 GMBHEPT000000-1290-983NYN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-06-0401. O

Event Narratives#

D

Patient 1

IN 2007, DR REALIZED AND REPORTED THAT THREE MONTHS EARLIER, A PT REC'D A BURN TO THE SKIN AROUND THE INCISION SITE, WHILE UNDERGOING A LUMBAR 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 (APPROX 19 MM ) AND THE LIGHT INTENSITY WAS SET AT 100%.

N

Patient 1

THE SYS AND THE MICROSCOPE LIGHT SOURCE WERE INSPECTED BY A SVC TECH ON APRIL 6, 2007 AND FOUND TO BE OPERATING WITHIN NORMAL TOLERANCES. THE PROD LABELING PROVIDES 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.