MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-11-19 for ECLIPSE H48 manufactured by Varian Medical Systems.
[128046511]
Varian ref: (b)(4). There have been no reports of illness or injury due to this issue. User caught the issue early enough, modified the plan and patient was properly treated. If treatment were to be performed without modification, the target would have been under dosed 10% during the course of the treatment, which could potentially contribute to a lower tumor control rate depending on the clinical situation. Primary root cause of the issue is missing requirement regarding the support of non-square ct images by algorithm.
Patient Sequence No: 1, Text Type: N, H10
[128046512]
When couch structures are added to an image set in the contouring workspace the resulting image size may be non-square. If the image size is non-square, a proton plan calculated with proton convolution superposition (pcs) algorithm may produce an incorrect isodose distribution resulting in a mistreatment. A customer reported an unexpected 6 mm shift of the isodose lines between two proton plans. The plans had been calculated for two separate ct images, one of which was square in x/y dimensions (512x512 pixels) and the other one was non-square (544x512 pixels). The non-square image had been created by inserting a couch structure to the image in the contouring workspace.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003793371-2018-00001 |
| MDR Report Key | 8084401 |
| Report Source | USER FACILITY |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-11-02 |
| Device Manufacturer Date | 2018-03-09 |
| Date Added to Maude | 2018-11-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. K. SEMONE |
| Manufacturer Street | 911 HANSEN WAY |
| Manufacturer City | PALO ALTO CA 943041028 |
| Manufacturer Country | US |
| Manufacturer Postal | 943041028 |
| Manufacturer Phone | 6504246833 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECLIPSE |
| Generic Name | TREATMENT PLANNING SYSTEM |
| Product Code | MUJ |
| Date Received | 2018-11-19 |
| Model Number | H48 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | 911 HANSEN WAY PALO ALTO CA 943041028 US 943041028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-19 |