MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-23 for PROTURA SOFTWARE MT6XSM1.7.1 manufactured by Medtec, Inc. D/b/a Civco Medical Solutions.
[76024810]
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.
Patient Sequence No: 1, Text Type: N, H10
[76024811]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932738-2016-00001 |
| MDR Report Key | 6586240 |
| Date Received | 2017-05-23 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-02-02 |
| Date Added to Maude | 2017-05-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES LEONG |
| Manufacturer Street | 1401 8TH ST SE |
| Manufacturer City | ORANGE CITY IA 51041 |
| Manufacturer Country | US |
| Manufacturer Postal | 51041 |
| Manufacturer Phone | 3192486502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROTURA SOFTWARE |
| Generic Name | PROTURA SOFTWARE |
| Product Code | JAI |
| Date Received | 2017-05-23 |
| Model Number | MT6XSM1.7.1 |
| Catalog Number | MT6XSM1.7.1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS |
| Manufacturer Address | 1401 8TH ST SE ORANGE CITY IA 51041 US 51041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-23 |