FDA.reportPublic FDA data

MAUDE MDR 8143094

MDR report key
8143094
Report number
9615010-2018-00015
Event key
0
Event type
3
Date of event
2018-11-09
Date received
2018-12-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. VERNON BROWN
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 900MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERYCARL ZEISS MEDITEC AG (OBERKOCHEN)FSONA302582-9902-000NAN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-0701. R

Event Narratives#

N

Patient 1

A DEVICE EVALUATION WAS NOT PERFORMED BECAUSE THE OPMI PENTERO 900 MICROSCOPE WAS SERVICED 3 WEEKS PRIOR TO THE INCIDENT AND NO ISSUES WERE IDENTIFIED. IN ADDITION, THE CUSTOMER COMMUNICATED THAT THE ISSUE WAS NOT CAUSED DUE TO ANY MALFUNCTION OF THE MICROSCOPE.

D

Patient 1

A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT RECEIVED A 1ST TO 2ND DEGREE BURN DURING A SPINAL SURGERY WHILE USING AN OPMI PENTERO 900 MICROSCOPE. THE BURN WAS EGG-SIZED AND WITHIN THE PROXIMITY OF THE SURGICAL AREA. THE HCP TREATED THE PATIENT'S BURN WITH A GREASE PAD. THE HCP COMMUNICATED THAT THE ISSUE WAS NOT AS A RESULT OF ANY MALFUNCTION WITH THE MICROSCOPE. THE HCP REPORTED THAT THE FOCUS LIGHT LINK WAS PURPOSELY SWITCHED OFF PRIOR TO THE SURGERY WHICH COMPROMISED A SAFETY MEASURE OF THE MICROSCOPE.