FDA.reportPublic FDA data

MAUDE MDR 2631069

MDR report key
2631069
Report number
9615010-2012-00007
Event key
0
Event type
3
Date of event
2012-05-17
Date received
2012-06-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JUDY BRIMACOMBE
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 PENTEROSURGICAL MICROSCOPECARL ZEISS SURGICAL GMBHEPT000000-0480-801R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-06-150

Event Narratives#

D

Patient 1

USER REP REPORTED THAT A SMALL BOLT (THE ECCENTRIC TIE ROD BOLT) BROKE AND THE NUT END OF THE BROKEN BOLT WAS EJECTED FROM THE OPMI PENTERO MICROSCOPE WHILE THE MICROSCOPE WAS BEING SET UP IN ADVANCE OF A SURGICAL PROCEDURE. THIS EVENT OCCURRED PRIOR TO DRAPING OF THE MICROSCOPE AND MOVEMENT OF THE MICROSCOPE TO THE PT. THE SURGERY WAS ABLE TO BE PERFORMED USING THE MICROSCOPE WITH ONE HAND GRIP UNLOCKED. NO INJURY OCCURRED TO THE PT OR OPERATING ROOM PERSONNEL.

N

Patient 1

A REPLACEMENT ECCENTRIC TIE ROD BOLT WAS DELIVERED TO THE USER FACILITY FOR REPAIR OF THE MICROSCOPE. THE SMALL ECCENTRIC TIE ROD BOLT IS PART OF THE LOCKING LEVER ASSEMBLY IN EACH HAND GRIP ARM. THE LOCKING LEVER ASSEMBLY IS USED TO LOCK THE MICROSCOPE'S HEAD HAND GRIP ARM POSITION AFTER ADJUSTMENT. NOTE: IF THE MICROSCOPE DRAPE WERE PRESENT, IT WOULD HAVE CONTAINED ANY FAILING MATERIAL. THE BROKEN ECCENTRIC TIE ROD BOLT PIECES HAVE NOT BEEN RETURNED TO THE MFR FOR COMPLAINT CONFIRMATION AND EVAL.