FDA.reportPublic FDA data

MAUDE MDR 2994758

MDR report key
2994758
Report number
9615010-2013-00004
Event key
0
Event type
3
Date of event
2013-01-31
Date received
2013-03-04
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
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 WALL MOUNTMICROSCOPE, SURGICAL, GENERAL & PLASTICCARL ZEISS MEDITEC AG (SITE OBERKOCHEN)EPTS7 WALL MOUNT000001-2011-542NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-03-040

Event Narratives#

D

Patient 1

A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A ROOT CANAL SURGICAL PROCEDURE, THE LAMP BULB BURST AND SOME OF THE DEBRIS ESCAPED THE VENTED LAMP HOUSING OF THE (B)(4) DENTAL MICROSCOPE; SOME OF THE DEBRIS MADE CONTACT WITH THE PATIENT, DOCTOR AND ASSISTANT. IT WAS FURTHER REPORTED THAT NO-ONE WAS INJURED. THE LAMP HOUSING IS LOCATED ON THE ARTICULATED S7 WALL MOUNT SYSTEM WHICH SUPPORTS THE MICROSCOPE HEAD. THE LIGHT FROM THE LAMP HOUSING IS TRANSMITTED TO THE MICROSCOPE HEAD VIA FIBER OPTIC.

N

Patient 1

A FIELD SERVICE ENGINEER (FSE) FOUND THAT THE BURST LAMP WAS USED BEYOND ITS 500 HOUR MAXIMUM SERVICE LIFE (ACTUAL TIME 2101.5 HOURS). THE BULB WAS REPLACED AND A COMPLETE FUNCTIONAL CHECK OF THE (B)(4) SURGICAL MICROSCOPE SYSTEM DETERMINED THAT IT WAS WORKING ACCORDING TO SPECIFICATION. THE USER MANUAL CAUTIONS, "CAUTION: THE XENON LAMP HAS A LIMITED SERVICE LIFE OF 500 HOURS! IF USED BEYOND ITS MAXIMUM SERVICE LIFE, THE XENON LAMP MAY EXPLODE. PLEASE REPLACE THE XENON LAMP IN DUE TIME." THE USER MANUAL ALSO STATES, "IF THE XENON LAMP IS USED BEYOND ITS MAXIMUM SERVICE OF 500 HOURS, A SUDDEN FAILURE MAY OCCUR. REPLACE THE XENON LAMP IN DUE TIME AND RESET THE SERVICE HOUR COUNTER TO "0." (B)(6).