FDA.reportPublic FDA data

MAUDE MDR 6586240

MDR report key
6586240
Report number
1932738-2016-00001
Event key
0
Event type
3
Date of event
2016-02-02
Date received
2017-05-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JAMES LEONG
Address
1401 8TH ST SE ORANGE CITY IA 51041 US
Phone
319-319-3192
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROTURA SOFTWAREPROTURA SOFTWAREMEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONSJAIMT6XSM1.7.1MT6XSM1.7.1N *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-05-230

Event Narratives#

N

Patient 1

UPON INVESTIGATION IT WAS DETERMINED THE POSITIONING DISCREPANCY RESULTS FROM THE EXECUTION OF POSITIONING SHIFTS VIA THE "SPLIT SHIFT" FUNCTIONALITY OF THE PROTURA SOFTWARE. THE SPLIT SHIFT FUNCTION ALLOWS FOR TRANSLATION SHIFTS TO BE EXPORTED AND EXECUTED BY THE LINAC PEDESTAL AND THEN THE PROTURA COMPENSATES ON THE ROTATIONAL ASPECTS OF THE MOVE. WHEN THE SPLIT SHIFT FUNCTIONALITY IS UTILIZED,THE PROTURA SYSTEM IS LOCKING INTO THE PIVOT POINT ASSOCIATED WITH THE INITIAL LOCATION PRIOR TO EXECUTING THE ROTATIONS AND SENDING THE TRANSLATIONAL REQUIREMENTS TO THE PEDESTAL. THE PROTURA IS THEN EXECUTING ROTATIONAL SHIFTS WITH RESPECT TO THE ORIGINAL PIVOT POINT LOCATION RATHER THAN THE PIVOT POINT THAT WOULD HAVE RESULTED FROM THE TRANSLATION AFTER THE SHIFTS MADE BY THE PEDESTAL. AS A RESULT, THE LARGER THE TRANSLATION (>3 CM) THE LARGER THE OFFSET TO ISOCENTER. THE SPLIT SHIFT FEATURE WHICH ALLOWS FOR >3 CM SHIFTS IS ONLY AVAILABLE ON PROTURA SOFTWARE VERSIONS 1.6.1, 1.7.0, AND 1.7.1 AND SET WITH A VARIAN INTERFACE. CIVCO WILL PROVIDE A SAFETY NOTIFICATION TO ALL USERS OF THESE VERSIONS OF THIS ISSUE AND DETAIL HOW TO SET UP THE SOFTWARE TO UTILIZE THE ALTERNATIVE SOFTWARE FUNCTIONALITY "ALL 6 DEGREES PROTURA". USING ALL 6 DEGREES PROTURA SETTING, THE PROBLEM IDENTIFIED WITH THE SOFTWARE DOES NOT EXIST. SOFTWARE VERSION AVAILABLE ON SITE.

D

Patient 1

USER FACILITY DEVELOPED A QUALITY ASSURANCE TEST FOR THE USE OF THE PROTURA SYSTEM AND VERIFY IT IS WITHIN 1 MM OF TREATMENT ISOCENTER. PRIOR TO USE, THE SITE IDENTIFIED THAT WHILE PERFORMING THE TESTING ON A PHANTOM IT WAS 2.5 MM OFF IN THE LATERAL DIRECTION AND 1.5 MM OFF IN THE VERTICAL DIRECTION WHEN TRANSLATIONAL OFFSETS BETWEEN 3-5 CM IN ALL THREE DIRECTIONS ARE EMPLOYED.