FDA.reportPublic FDA data

MAUDE MDR 785478

MDR report key
785478
Report number
2431026-2006-00011
Event key
0
Event type
3
Date of event
2006-07-25
Date received
2006-09-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1OPMIMICROSCOPECARL ZEISS SURGICALEPT1-FC303322*NRY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-09-010

Event Narratives#

D

Patient 1

THE MICROSCOPE FELL FROM THE CEILING MOUNTED SUSPENSION. IT WAS CAUGHT BY THE SURGEON DURING SURGERY. THERE WAS NO REPORT OF INJURY FROM THE EVENT. ON JUNE 02 OF 2006, THE MICROSCOPE WAS SERVICED BY A ZEISS SERVICE ENGINEER. THE LOCKING MECHANISMS WERE INSPECTED AND FOUND TO BE SECURED. THERE ARE THREE (3) SECURING SCREWS THAT HOLD THE MICROSCOPE IN PLACE. FOR THE MICROSCOPE TO FALL OFF FROM THE CEILING MOUNTED SUSPENSION, ALL THREE (3) SECURING SCREWS ARE LOOSE. ON THE DATE OF THE EVENT, LOCKING SCREWS CAME OFF. THEY WERE FOUND IN THE SURGERY DRAPES. AFTER THE INCIDENT, THE LOCKING MECHANISMS WERE INSPECTED AND FOUND TO BE SECURED. THERE WERE NO SIGNS OF EITHER DAMAGE OR WEAR ON THE MICROSCOPE AND ON THE LOCKING MECHANISMS. THE MANUAL OF THE MICROSCOPE STATED THAT BEFORE USING THE EQUIPMENT, ALWAYS ENSURE THAT SECURING SCREWS ARE TIGHTENED FIRMLY. THE EVENT INDICATED THAT ALL THREE SECURING SCREWS WERE NOT TIGHTENED BEFORE USE. THE DISTRIBUTOR REPORTED THE EVENT TO THE MANUFACTURE ON AUGUST 02, 2006.