MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-01-18 for ECLIPSE manufactured by Varian Medical Systems.
[20684412]
An internal employee of varian medical systems became aware of a anecdotal report of a software anomaly in the eclipse treatment planning software from an overseas distributor located in japan. The anomaly was discovered during acceptance testing of a new eclipse installation. Eclipse software supports a technique known as dynamic conformal arc. This allows eclipse to combine rotational arcing field techniques with a dynamic mlc. Eclipse will allow up to 99 segments to be designated for an arc field without the use of a dynamic mlc. A dynamic mlc has the ability to designate up to 500 arc segments. If more than 99 segments are entered for an arc treatment in the dynamic mlc's properties window, it will cause an overflow condition in the dose calculation engine of eclipse that results in erroneous plan normalization and subsequently causes incorrect mu's to be computed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1124791-2002-00001 |
| MDR Report Key | 371906 |
| Report Source | 07 |
| Date Received | 2002-01-18 |
| Date of Report | 2001-12-21 |
| Date of Event | 2001-12-21 |
| Date Mfgr Received | 2001-12-21 |
| Device Manufacturer Date | 2001-09-01 |
| Date Added to Maude | 2002-01-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | TOM MCCONNELL |
| Manufacturer Street | 3140 HANSEN WAY M/S F-055 |
| Manufacturer City | PALO ALTO CA 943041058 |
| Manufacturer Country | US |
| Manufacturer Postal | 943041058 |
| Manufacturer Phone | 6504246206 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECLIPSE |
| Generic Name | TREATMENT PLANNING SOFTWARE |
| Product Code | MVJ |
| Date Received | 2002-01-18 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | VERSION 6.5 BUILD 7.0.19 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 361034 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | 700 HARRIS ST., SUITE 109 CHARLOTTESVILLE VA 22903 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-01-18 |