FDA.reportPublic FDA data

MAUDE MDR 2746927

MDR report key
2746927
Report number
9615010-2012-00010
Event key
0
Event type
3
Date of event
2012-08-17
Date received
2012-09-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JUDY BRIMACOMBE
Address
5160 HACIENDA DR. 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 LUMERA IMICROSCOPE, OPERATING, OPHTHALMIC, ACCARL ZEISS MEDITEC AG (OBERKOCHEN SITE)EPTI (W/FLOOR STAND)Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-09-120

Event Narratives#

D

Patient 1

AT THE CONCLUSION OF A CATARACT EXTRACTION PROCEDURE, A NURSE USED HER ELBOW TO MOVE THE OPMI LUMERA I SURGICAL MICROSCOPE MOUNTED ON A FLOOR STAND OUT OF THE WAY. THE CONTACT RESULTED IN THE BEAM SPLITTER WITH ATTACHED BINOCULARS, ASSISTANT BINOCULARS AND VIDEO CAMERA SEPARATING FROM THE MICROSCOPE BODY AND FALLING TO THE FLOOR. THE MICROSCOPE WAS NOT POSITIONED OVER THE PATIENT AT THE TIME. NO ONE WAS INJURED.

N

Patient 1

FAILURE TO ENSURE THAT ALL SECURING SCREWS ARE FIRMLY TIGHTENED BEFORE EACH USE COULD RESULT IN ATTACHMENTS TO THE MICROSCOPE BODY COMING LOOSE AND FALLING. A FIELD SERVICE ENGINEER EXAMINED THE MICROSCOPE AND FOUND NO ISSUES WITH THE USER ADJUSTABLE KNURLED SECURING SCREW THAT IS USED TO LOCK THE BEAM SPLITTER WITH ATTACHED ACCESSORIES TO THE MICROSCOPE BODY. THE MAIN BINOCULARS, ASSISTANT BINOCULARS, CAMERA AND VIDEO INPUT WERE DAMAGED AS A RESULT OF THE FALL AND REQUIRED REPLACEMENT. THE BINOCULARS WERE REPLACED, OTHER REPLACEMENT PARTS ORDERED AND A PREVENTIVE MAINTENANCE WAS PERFORMED. THE FIELD SERVICE ENGINEER EXPLAINED TO THE CUSTOMER WHY THE SCREW MAY HAVE COME LOOSE, REMINDED THEM THAT THEY SHOULD CHECK THE SECURING SCREWS BEFORE EVERY USE AND ASKED THAT THEY EXPLAIN THIS TO THE DOCTORS AND NURSES. THE OPMI LUMERA I USER MANUAL STATES: ?WARNING?, ?RISK OF INJURY CAUSED BY ACCESSORIES FALLING DOWN?, ?BEFORE EVERY USE AND AFTER RE-EQUIPPING THE SYSTEM MAKE SURE THAT THE ACCESSORY MODULES ARE SECURELY LOCKED IN POSITION. MAKE SURE ALL SECURING SCREWS ARE FIRMLY TIGHTENED.?