XKNIFE 5.0 INSTALL KIT XK5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2012-11-16 for XKNIFE 5.0 INSTALL KIT XK5 manufactured by Integra Burlington, Ma, Inc..

Event Text Entries

[3042831] "x1 and y1 jaws showing as -3. 5 in (b)(4), should be +3. 5 due to software error. " the error message occurs in the (b)(4) system. The (b)(4)system is third party software integrated with the linac that verifies the proper position of the couch, collimator, gantry and any beam modifiers before treatment is delivered. Xknife is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (linac) based treatment. The software installation is conducted prior to scheduling the use of the system to treat patients. Therefore, there was no patient contact.
Patient Sequence No: 1, Text Type: D, B5


[10296117] 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 Number1222895-2012-00046
MDR Report Key2845285
Report Source00,07
Date Received2012-11-16
Date of Report2012-11-16
Date Mfgr Received2012-08-24
Date Added to Maude2013-02-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
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 NameXKNIFE 5.0 INSTALL KIT
Generic NameNEURO
Product CodeKPQ
Date Received2012-11-16
Catalog NumberXK5
Lot Number5.0.1
OperatorOTHER
Device AvailabilityY
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 2012-11-16

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