ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM 8065750290

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2014-03-19 for ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM 8065750290 manufactured by Alcon - Irvine Technology Ctr.

Event Text Entries

[4404637] A customer reported the system shut down during a case. The system was exchanged to complete the case. There was no impact to the pt.
Patient Sequence No: 1, Text Type: D, B5


[11896751] Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable info becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2028159-2014-00416
MDR Report Key3834529
Report Source00,01
Date Received2014-03-19
Date of Report2014-02-20
Date of Event2014-02-19
Date Mfgr Received2014-02-20
Device Manufacturer Date2007-01-01
Date Added to Maude2014-06-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJANET MORAN
Manufacturer Street6201 SOUTH FREEWAY, R3-48
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152742
Manufacturer G1ALCON - IRVINE TECH CTR
Manufacturer Street15800 ALTON PKWY.
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM
Generic NameENDOILLUMINATOR
Product CodeMPA
Date Received2014-03-19
Model NumberNA
Catalog Number8065750290
Lot NumberNA
ID Number1.18-2.18
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON - IRVINE TECHNOLOGY CTR
Manufacturer Address15800 ALTON PKWY. IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2014-03-19

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