CUSA EXCEL 36KHZ C2602

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 2013-11-20 for CUSA EXCEL 36KHZ C2602 manufactured by Integra Neurosciences, Ltd.

Event Text Entries

[16915020] Straight handpiece was not cooling off and water drips. Additional info has been requested.
Patient Sequence No: 1, Text Type: D, B5


[16941422] To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006697299-2013-00077
MDR Report Key3770261
Report Source06
Date Received2013-11-20
Date of Report2013-11-20
Date Mfgr Received2013-10-29
Date Added to Maude2014-05-19
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 ContactLINDA SERENTINO
Manufacturer Street315 ENTERPRISE DR
Manufacturer Phone6099365560
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCUSA EXCEL 36KHZ
Generic NameULTROSONIC SURGICAL PRODUCTS
Product CodeLBK
Date Received2013-11-20
Catalog NumberC2602
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA NEUROSCIENCES, LTD
Manufacturer AddressANDOVER HAMPSHIRE SP104DR UK SP104DR


Patients

Patient NumberTreatmentOutcomeDate
10 2013-11-20

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