FDA.reportPublic FDA data

MAUDE MDR 3894155

MDR report key
3894155
Report number
9615010-2014-00006
Event key
0
Event type
3
Date of event
2014-01-08
Date received
2014-02-06
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
CARL ZEISS STRASSE 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 PICO ON S100 FLOOR STANDMICROSCOPE, SURGICAL, GENERAL AND PLACARL ZEISS MEDITEC AGFSOS100 FLOORSTAND000000-1403-542NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-02-060

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE CUSTOMER HEARD A NOISE AND WENT INTO THE PROCEDURE ROOM. THEY FOUND THE LAMP HOUSING (XENON POWER SUPPLY ILLUMINATION UNIT) HAD FALLEN AND WAS HANGING BY THE CABLES FROM THEIR OPMI PICO MICROSCOPE S100 FLOOR STAND. THE CUSTOMER CONFIRMED THAT NO ONE WAS INJURED.

N

Patient 1

THE FIELD SERVICE ENGINEER (FSE) FOUND THAT ALL FOUR BOLTS SECURING THE XENON POWER SUPPLY ILLUMINATION UNIT MOUNTING PLATE TO THE S100 STAND WERE BROKEN. THE MICROSCOPE WAS REPAIRED. SITE CONTACT IS SAME AS INITIAL REPORTER.