FDA.reportPublic FDA data

MAUDE MDR 1633730

MDR report key
1633730
Report number
2090040-2010-00001
Event key
0
Event type
3
Date of event
2010-02-01
Date received
2010-03-17
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
MS. MOIRA BARTON-VARTY
Address
10232 S. 51ST STREET PHOENIX AZ 85044 US
Phone
480-480-4807
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1N/ANKXASCENT HEALTHCARE SOLUTIONSNKX80657408378065740837830993Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-03-170

Event Narratives#

D

Patient 1

DURING THE PROCEDURE THE TIP OF THE PHACO BROKE OFF. THE TIP WAS RETRIEVED AND NO PATIENT INJURY WAS REPORTED.

N

Patient 1

THE PHACO TIP WAS VISUALLY INSPECTED AND FOUND TO HAVE BROKEN ACROSS THE ABS PORT OF THE PHACO TIP. THE MOST PROBABLE CAUSE OF THE DEVICE FAILURE IS DUE TO FATIGUE. THE FATIGUE IS MOST LIKELY FROM THE ULTRASONIC ENERGY AND CAUSED A CRACK TO FORM.(B)(4). THIS DEVICE WAS REPROCESSED BEFORE ASCENT STOPPED THE REPROCESSING OF THIS MODEL.THE DEVICE HISTORY RECORD FOR THE RETURNED DEVICE INDICATES THAT THE DEVICE PASSED ALL APPLICABLE INSPECTIONS AND TESTS PRIOR TO RELEASE.