N/A 8065740837

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-03-17 for N/A 8065740837 manufactured by Ascent Healthcare Solutions.

Event Text Entries

[1481736] During the procedure the tip of the phaco broke off. The tip was retrieved and no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5


[8596158] 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2090040-2010-00001
MDR Report Key1633730
Report Source05,06,07
Date Received2010-03-17
Date of Report2010-03-17
Date of Event2010-02-01
Date Mfgr Received2010-02-24
Device Manufacturer Date2009-08-31
Date Added to Maude2010-12-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS. MOIRA BARTON-VARTY
Manufacturer Street10232 S. 51ST STREET
Manufacturer CityPHOENIX AZ 85044
Manufacturer CountryUS
Manufacturer Postal85044
Manufacturer Phone4807635300
Manufacturer G1ASCENT HEALTHCARE SOLUTIONS
Manufacturer Street10232 SOUTH 51ST STREET
Manufacturer CityPHOENIX AZ 85044
Manufacturer CountryUS
Manufacturer Postal Code85044
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameN/A
Generic NameNKX
Product CodeNKX
Date Received2010-03-17
Returned To Mfg2010-03-03
Model Number8065740837
Catalog Number8065740837
Lot Number830993
Device Expiration Date2011-08-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerASCENT HEALTHCARE SOLUTIONS
Manufacturer Address10232 SOUTH 51ST STREET PHOENIX AZ 85044 US 85044


Patients

Patient NumberTreatmentOutcomeDate
10 2010-03-17

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