FDA.reportPublic FDA data

MAUDE MDR 2021327

MDR report key
2021327
Report number
9615010-2011-00001
Event key
0
Event type
3
Date of event
2010-12-05
Date received
2011-02-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JUDY BRIMACOMBE
Address
CARL - ZEISS - STR. 22 OBERKOCHEN 73447 GM
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OPMI PENTEROSURGICAL MICROSCOPECARL ZEISS SURGICAL GMBHEPTY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-02-0801. O

Event Narratives#

N

Patient 1

THE SYSTEM EXPERIENCED AN ELECTRICAL MALFUNCTION. AS A RESULT, AND IN ACCORDANCE WITH ITS INTENDED FUNCTION, THE SYSTEM LOCKS (BRAKES) WERE ACTIVATED. THE OPERATOR'S MANUAL INDICATES THAT THE LOCKS (BRAKES) CAN BE OVERRIDEN BY THE OPERATOR BY HAND, HOWEVER, THE SURGEON EITHER WAS NOT AWARE OF THIS EMERGENCY PROCEDURE OR DID NOT CHOOSE TO USE THIS PROCEDURE. THE SYSTEM WAS EVALUATED BY A SERVICE TECH, FOUND THE SOURCE OF THE ELECTRICAL MALFUNCTION AND REPAIRED IT. THE SERVICE TECH CONFIRMED THAT THE EMERGENCY FUNCTION WAS IN PROPER WORKING ORDER.

D

Patient 1

DURING A NEUROSURGERY, CLIPPING OPERATION WHEREIN THE OPMI PENTERO SURGICAL MICROSCOPE WAS IN USE, THE SYSTEM DETECTED A MALFUNCTION. THE MALFUNCTION CAUSED THE JOINTS (BRAKES) OF THE SUSPENSION SYSTEM WHICH HOLDS THE HEAD OF THE MICROSCOPE TO LOCK. AS A RESULT OF THE SYSTEM BEING LOCKED, THE SURGEON WAS NOT ABLE TO CONTROL THE POSITIONING OF THE HEAD OF THE MICROSCOPE. THE SURGEON HAD TO MOVE THE PT'S BED IN ORDER TO CHANGE THE SURGICAL FIELD OF VIEW. THE SURGERY WAS COMPLETED WITHOUT INCIDENT; THE PT WAS NOT HARMED. HOWEVER, THE DURATION OF THE SURGERY WAS EXTENDED DUE TO THE INCIDENT.