FDA.reportPublic FDA data

MAUDE MDR 768486

MDR report key
768486
Report number
2431026-2006-00017
Event key
0
Event type
3
Date of event
2006-09-13
Date received
2006-10-11
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
1OPMISURGICAL MICROSCOPECARL ZEISS SURGICAL GMBHEPTPENTERO**NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-10-1101. O

Event Narratives#

D

Patient 1

A PENTERO WAS USED FOR PERFORMING MICRO LUMBAR DISC PROCEDURES. THE ILLUMINATION INTENSITY WAS SET AT MAXIMUM FOR DURATION OF 1 HOUR. THE WORKING DISTANCE TO THE SKIN WAS AROUND 250MM. THE SPOT ILLUMINATION WAS NOT USED DURING OPERATIONS. AT THE END OF THE PROCEDURES, 2 PT'S REC'D SECOND DEGREE BURNS. AT THE END OF THE FIRST PROCEDURE, THE SURGEON NOTICED THE BURN ON THE SURROUNDING AREA OF THE INCISION OF THE FIRST PT HAD THE SHAPE OF A CIRCLE. HE BELIEVED THAT THE BURN WAS A REACTION TO THE LOBAN DRAPE USED IN OPERATION. AT THE END OF THE SECOND PROCEDURE, THE SURGEON NOTICED THE BURN ON THE SECOND PT ALSO HAD THE SHAPE OF A CIRCLE. HE BELIEVED THAT IT WAS FROM THE LIGHT, NOT FROM ANY OTHER SOURCE.

N

Patient 1

A ZEISS SURGICAL FIELD SERVICE ENGINEER EVALUATED THE PENTERO. IT FUNCTIONS NORMALLY.