MAUDE Adverse Event Report: MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS PROTURA SOFTWARE

Model Number MT6XSM1.7.1

Device Problems Computer Software Problem (1112); Application Program Problem (2880); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: PROTURA SOFTWARE
• Type of Device: PROTURA SOFTWARE
• Manufacturer (Section D): MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS; 1401 8th st se; orange city IA 51041
• Manufacturer Contact: james leong ; 1401 8th st se; orange city, IA 51041 ; 3192486502
• MDR Report Key: 6586240
• MDR Text Key: 76024810
• Report Number: 1932738-2016-00001
• Device Sequence Number: 1
• Product Code: JAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MT6XSM1.7.1
• Device Catalogue Number: MT6XSM1.7.1
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1