FDA.reportPublic FDA data

MAUDE MDR 1463653

MDR report key
1463653
Report number
2431026-2009-00004
Event key
0
Event type
3
Date of event
2009-07-17
Date received
2009-09-02
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
JUDY BRIMACOMBE
Address
5160 HACIENDA DR DUBLIN CA 94568 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OPMI PENTEROSURGICAL MICROSCOPECARL ZEISS SURGICAL, GMBHEPTY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-09-0201. O

Event Narratives#

N

Patient 1

THE SYSTEM AND MICROSCOPE WERE INSPECTED BY A SERVICE TECHNICIAN IN 2009. THE TECHNICIAN CHECKED ALL FUNCTIONS AND DETERMINED THE UNIT TO BE WORKING PROPERLY. THE PRODUCT LABELING PROVIDES INFORMATION REGARDING PHOTOXIC TISSUE INJURY RECOMMENDING, AMONG OTHER THINGS, USE OF THE LOWEST LIGHT SETTING POSSIBLE, REDUCING THE EXPOSURE TIME TO A MINIMUM, AND TAKING PRECAUTIONS TO IRRIGATE THE SURGICAL FIELDS. THE SURGEON HAD BEEN TRAINED ON THE USE OF THE DEVICE.

D

Patient 1

THE USER FACILITY REPORTED AN INCIDENT DESCRIBED AS A PATIENT BURN. THE PATIENT UNDERWENT A MASTECTOMY AND FREE FLAP SURGERY REPORTED TO LAST FOR 12 HOURS USING SURGICAL MICROSCOPE. A THIRD DEGREE BURN APPROXIMATELY 2" BY 1", OVAL IN SHAPE APPEARED SUPERIOR TO THE INCISION DURING THE SURGERY. AN INCISION DRAPE WAS NOT USED TO COVER THE SURGICAL AREA. NO MEDICAL/SURGICAL INTERVENTION WAS NECESSARY TO PREVENT FURTHER DAMAGE.