FDA.reportPublic FDA data

MAUDE MDR 2579599

MDR report key
2579599
Report number
9615010-2012-00003
Event key
0
Event type
3
Date of event
2012-04-13
Date received
2012-05-15
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
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 LUMERA 700 FLOOR STANDSURGICAL MICROSCOPECARL ZEISS MEDITEC AGEPT305953-9900-000Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-05-1501. O

Event Narratives#

D

Patient 1

THERE HAS BEEN NO REPORT OF PT INJURY. A XENON LAMP BURST INSIDE THE LAMP MODULE OF THE OPMI LUMERA 700 SURGICAL MICROSCOPE TOWARDS THE END OF A CORNEAL SUTURE SURGICAL PROCEDURE. PIECES OF GLASS FROM THE BURST LAMP LANDED IN THE STERILE FIELD ON THE DRAPE COVERING THE PT IN THE LOWER CHEST AND FEET AREA. THE SURGICAL PROCEDURE WAS COMPLETED WITH THE USE OF A BACK-UP MICROSCOPE AFTER AN APPROXIMATE TEN MINUTE DELAY.

N

Patient 1

THE MFR RECOMMENDS THAT THE XENON LAMP BE REPLACED AFTER A MAXIMUM OF 500 OPERATING HOURS OR EVERY SIX MONTHS. THE NUMBER OF HOURS THE SYS HAD BEEN USED IS NOT KNOWN.