L300 SURGICAL ILLUMINATOR 90123

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-08-28 for L300 SURGICAL ILLUMINATOR 90123 manufactured by Integra Burlington, Ma Inc..

Event Text Entries

[15507731] Customer initially reports the unit was involved in an incident. The lamp literally exploded taking out the reflectors. Some parts were replaced by biomedical department in an attempt to repair the unit. On (b)(4) 2012, biomedical dept and surgical equipment tech report no real "explosion", the device smoked and the device lamp and both reflectors were significantly damaged. This occurred during "back" surgery and there was no harm to pt or staff. Device was quickly replaced and there was no real downtime.
Patient Sequence No: 1, Text Type: D, B5


[15691690] To date the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1222895-2012-00025
MDR Report Key2719410
Report Source06
Date Received2012-08-28
Date of Report2012-08-28
Date Mfgr Received2012-08-21
Date Added to Maude2012-12-14
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 ContactSANDRA LEE
Manufacturer Street315 ENTERPRISE DR.
Manufacturer Phone6099366828
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameL300 SURGICAL ILLUMINATOR
Generic NameCOGENT 270 SURGICAL ILLUMINATOR
Product CodeFSW
Date Received2012-08-28
Catalog Number90123
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA BURLINGTON, MA INC.
Manufacturer AddressBURLINGTON MA 01803 US 01803


Patients

Patient NumberTreatmentOutcomeDate
10 2012-08-28

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