FDA.reportPublic FDA data

MAUDE MDR 3130287

MDR report key
3130287
Report number
9615010-2013-00013
Event key
0
Event type
3
Date of event
2013-04-22
Date received
2013-05-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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 PROERGO WITH S7 FLOOR STANDMICROSCOPE, SURGICAL, GENERAL AND PLASTICCARL ZEISS MEDITEC AGEPTPROERGO000000-1087-851NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-05-220

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE ASSEMBLY, CONSISTING OF THE BINOCULAR TUBE AND EYE PIECES, FELL OFF WHILE POSITIONING AN OPMI PROERGO SURGICAL MICROSCOPE FOR A ROOT CANAL PROCEDURE. THE FALLING ASSEMBLY CONTACTED THE PATIENT'S SHOULDER AND LANDED IN THE HEALTHCARE PROVIDER'S LAP. NEITHER THE PATIENT, NOR THE HEALTHCARE PROVIDER REQUIRED MEDICAL ATTENTION. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT, USING A REPLACEMENT MICROSCOPE, AFTER AN APPROXIMATELY 8-10 MINUTE DELAY.

N

Patient 1

A FIELD SERVICE REPRESENTATIVE (FSE) PERFORMED AN ON-SITE INSPECTION OF THE OPMI PROERGO SURGICAL MICROSCOPE SYSTEM. HE RE-SECURED THE BINOCULAR TUBE AND EYE PIECES, ONTO THE MICROSCOPE HEAD AND REBALANCED THE SYSTEM. ALL FUNCTIONS AND CONTROLS WERE FOUND TO BE OPERATING PROPERLY. THE FSE ALSO PROVIDED THE CLINICAL ASSISTANT PROFESSOR AND CLINICAL ASSOCIATE PROFESSOR WITH A DEMONSTRATION OF THE OPERATION OF ALL FUNCTIONS AND CONTROLS. THE USER MANUAL INSTRUCTS THE USER TO PERFORM THE FOLLOWING SAFETY MEASURES BEFORE EVERY USE: "TO PREVENT ACCESSORIES FROM FALLING DOWN, CHECK BEFORE EVERY USE THAT ACCESSORIES ARE SECURELY LOCKED IN POSITION AND SECURING SCREWS ARE FIRMLY TIGHTENED." SITE CONTACT INFORMATION: DR (B)(6), CLINICAL ASSISTANT PROFESSOR; (B)(6).