EXCEL 36KHZ STRAIGHT HANDPIECE C2602

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-02-04 for EXCEL 36KHZ STRAIGHT HANDPIECE C2602 manufactured by Integra Neurosciences, Ltd..

Event Text Entries

[16059805] The first report of two involving a 36 khz handpiece. A 36khz cusa handpiece got very hot during use. The first handpiece completely stopped working. The unit was in use 2-3 minutes when the problem occurred. The settings were 100 aspiration, 100 amplitude, 3 ml/minute. The surgery was not delayed as a result of this issue. Did the surgeon or pt did not incur an injury as a result of this problem.
Patient Sequence No: 1, Text Type: D, B5


[16386322] 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 Number3006697299-2014-00009
MDR Report Key3753416
Report Source05
Date Received2014-02-04
Date of Report2014-01-10
Date of Event2014-01-03
Date Mfgr Received2014-01-10
Date Added to Maude2014-05-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLINDA SERENTINO
Manufacturer Street315 ENTERPRISE DRIVE
Manufacturer Phone6099365560
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEXCEL 36KHZ STRAIGHT HANDPIECE
Generic NameULTRASONIC SURGICAL PRODUCTS
Product CodeLBK
Date Received2014-02-04
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 2014-02-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.