FDA.reportPublic FDA data

MAUDE MDR 1487302

MDR report key
1487302
Report number
2431026-2009-00005
Event key
0
Event type
3
Date of event
2009-08-18
Date received
2009-09-25
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
12009-09-2501. O

Event Narratives#

D

Patient 1

THE USER FACILITY REPORTED AN INCIDENT DESCRIBED AS A PT BURN. THE PT UNDERWENT A LEFT TYMPANOMASTOIDECTOMY REPORTED TO LAST FOR 4 HOURS USING SURGICAL MICROSCOPE. A SECOND DEGREE BURN, APPROX 2-3 CM IN DIAMETER, APPEARED NEXT TO THE WOUND IMMEDIATELY AT THE END OF THE SURGERY DURING SKIN CLOSURE. AN INCISION DRAPE WAS NOT USED TO COVER THE SURGICAL AREA. SILVADENE WAS APPLIED TO THE BURN IN ORDER TO PREVENT FURTHER INJURY.

N

Patient 1

THE SYSTEM AND MICROSCOPE WERE INSPECTED BY A SERVICE TECH ON 08/20/2009. THE TECH CHECKED ALL FUNCTIONS AND DETERMINED THE UNIT TO BE WORKING PROPERLY. THE PRODUCT LABELING PROVIDES INFO REGARDING PHOTOTOXIC 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 FIELD. THE SURGEON HAD BEEN TRAINED ON THE USE OF THE DEVICE.