FDA.reportPublic FDA data

MAUDE MDR 970250

MDR report key
970250
Report number
2431026-2006-00009
Event key
0
Event type
3
Date of event
2006-06-10
Date received
2006-07-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
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 VARIO / S88ACCESSORY TO SURGICAL MICROSCOPECARL ZEISS SURGICAL GMBHEPT1195-499**NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-07-130

Event Narratives#

D

Patient 1

DURING A ROUTINE SERVICE CALL FOR THE OPMI VARIO/S88 THE FIELD SERVICE REPRESENTATIVE INADVERTENTLY NEGLECTED TO REINSTALL THE DOVETAIL, A GROOVED METAL PLATE REQUIRED FOR MOUNTING THE LASER MICROMANIPULATOR WHICH IS USED DURING CERTAIN SURGERIES. IN 2006, THE SURGEON ATTEMPTED TO USE THE OPMI VARIO DURING SURGERY. WHEN ATTEMPTING TO MOUNT THE LASER MICROMANIPULATOR. HE WAS UNABLE TO DO SO AS THE DOVETAIL WAS NOT INSTALLED. THE SURGEON STOPPED THE SURGERY AS RESCHEDULED IT . HE NOTIFIED THE MANUFACTURER 3 DAYS LATER.