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 01,05 report with the FDA on 2012-09-28 for ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM 8065750290 manufactured by Alcon - Irvine Technology Center.

Event Text Entries

[20393412] The company rep examined the system and cleaned the lamp's cooling system. Preventive maintenance was performed. The system was then tested and met product specs. No samples were returned for eval and no add'l info provided related to this event. For this reason, steps could not be taken to replicate or confirm the reported event. The root cause is unk. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[20418508] A nurse reported during a procedure, the system's light source kept turning off. Another system's light source was used to complete the case. There was no harm to the pt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028159-2012-01496
MDR Report Key2769748
Report Source01,05
Date Received2012-09-28
Date of Report2012-08-31
Date of Event2012-09-30
Date Mfgr Received2012-08-31
Device Manufacturer Date2006-08-01
Date Added to Maude2012-11-02
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 ContactPAUL NITSCHMANN
Manufacturer Street6201 SOUTH FREEWAY, R3-16
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152440
Manufacturer G1ALCON - IRVINE TECHNOLOGY
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 Received2012-09-28
Model NumberNA
Catalog Number8065750290
Lot NumberNA
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALCON - IRVINE TECHNOLOGY CENTER
Manufacturer Address15800 ALTON PKWY. IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2012-09-28

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