MAUDE MDR 791770

MDR report key
791770
Report number
2431026-2006-00018
Event key
0
Event type
3
Date of event
2006-11-02
Date received
2006-12-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR. KENT JONES
Address
5160 HACIENDA DRIVE 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 PENTERO/STAND PENTEROSURGICAL MICROSCOPECARL ZEISS SURGICAL GMBHEPT*000000-1290-983*NYN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-12-0101. O

Event Narratives#

D

Patient 1

USER FACILITY REPORTS THAT A CHILD RECEIVED A SECOND-DEGREE BURN ON THE INCISION SITE, THE SIZE OF WHICH WAS SIMILAR TO A US 50 CENT COIN. AFTER SURGERY, THE SURGEON NOTICED THAT THE WRIST WAS BLISTERING. THE SURGERY WAS ON THE RIGHT INDEX FINGER, WHICH WAS ALMOST COMPLETELY SEVERED. A SECOND INCISION WAS MADE IN THE WRIST FOR THE BINDING AND SKIN GRAFTS. THE BURN WAS ON THE VERY EDGE OF THE INCISION POINT ON THE WRIST. AN INCISION DRAPE WAS USED PREPARATORY TO THE SURGICAL PROCEDURE.

N

Patient 1

THE SYSTEM AND THE MICROSCOPE LIGHT SOURCE WERE INSPECTED BY A SERVICE TECHNICIAN AND FOUND TO BE OPERATING WITHIN NORMAL TOLERANCES. THE PRODUCT LABELING PROVIDES INFORMATION 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. THE MANUFACTURER RECOMMENDS USING THE APERTURE SETTING TO LIMIT UNNECESSARY EXPOSURE OF TISSUE SURROUNDING THE INCISION SITE.