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 2013-11-22 for ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM 8065750290 manufactured by Alcon - Irvine Technology Center.

Event Text Entries

[4138848] A customer reported that a system shutdown on its own during a procedure. The system was rebooted and the surgery was completed with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


[11560830] 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 information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2028159-2013-02243
MDR Report Key3578702
Report Source00,01
Date Received2013-11-22
Date of Report2013-10-28
Date of Event2013-10-23
Date Mfgr Received2013-10-28
Device Manufacturer Date2006-04-01
Date Added to Maude2014-02-25
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 FDA0
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 TECHNOLOGY CENTER
Manufacturer Street15800 ALTON PARKWAY
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 Received2013-11-22
Model NumberNA
Catalog Number8065750290
Lot NumberNA
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON - IRVINE TECHNOLOGY CENTER
Manufacturer Address15800 ALTON PARKWAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2013-11-22

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