FDA.reportPublic FDA data

MAUDE MDR 917659

MDR report key
917659
Report number
2431026-2007-00013
Event key
0
Event type
3
Date of event
2007-08-21
Date received
2007-09-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
KERT JONES
Address
22 CARL ZEISS STRASSE OBERKOCHEN 73447 GM
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OPMI VARIOSURGICAL MICROSCOPECARLS ZEISS SURGICAL GMBHEPTNYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-09-2401. O

Event Narratives#

D

Patient 1

A PT HAS RECEIVED A 3RD DEGREE BURN AFTER 45 MINUTES OF SURGERY (STAPEDOCTOMY). LIGHT INTENSITY OF THE SURGICAL MICROSCOPE WAS SET AT ABOUT 50%. THE CUSTOMER MOVED THE ASSISTANT SCOPE FROM ONE SIDE OF THE MICROSCOPE TO THE OTHER SIDE WITHOUT REBALANCING THE MICROSCOPE. TO AVOID REPOSITIONING, THE UNBALANCED MICROSCOPE, HE INCREASED THE ILLUMINATED AREA WHICH THEREFORE ILLUMINATED UNPROTECTED AND UNIRRIGATED SKIN.

N

Patient 1

BY NOT REBALANCING THE MICROSCOPE AFTER MOVING THE ASSISTANT SCOPE, THE SURGEON ILLUMINATED UNPROTECTED SKIN PERIPHERALLY WHICH LED TO A LIGHT INDUCED BURN. THE HOSPITAL DID NOT RELEASE PT DETAILS. THE DEVICE WAS INSPECTED BY A SERVICE TECHNICIAN. THE BALANCING SYSTEM AND ALL OTHER FUNCTIONS WERE FOUND TO BE IN GOOD WORKING CONDITION.