FDA.reportPublic FDA data

MAUDE MDR 8049027

MDR report key
8049027
Report number
9615010-2018-00014
Event key
0
Event type
3
Date of event
2018-10-08
Date received
2018-11-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
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 VARIOMICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERYCARL ZEISS MEDITEC AG (OBERKOCHEN)FSON/A000000-1026-700N/AY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-0701. O

Event Narratives#

N

Patient 1

ACCORDING TO THE MANUFACTURER THE FAILURE OF THE FOCUS FUNCTION OCCURRED DUE TO AN INCORRECT FITTING OF A THIRD PARTY DRAPE TO THE DEVICE. THE DRAPE GOT TANGLED AROUND THE FOCUS KNOB CAUSING IT TO BECOME STUCK. THE USER MANUAL INSTRUCTS THE USER TO ENSURE THE PROPER DRAPING OF THE SYSTEM TO ALLOW PROPER MOVEMENT OF THE MICROSCOPE. (B)(4).

D

Patient 1

A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE FOCUS FUNCTION OF THE OPMI VARIO MICROSCOPE STOPPED WORKING AFTER 1 HOUR AND 30 MINUTES INTO A SURGERY. THE SYSTEM DISPLAYED ERROR #12, RELATED TO THE ZOOM END POSITION. THE HCP DECIDED TO ABORT THE PROCEDURE AND RESCHEDULED IT FOR A LATER DATE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.