MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2008-11-18 for INTERPLANT PROSTATE BRACHYTHERAPY RTP SYSTEM RELEASE 3.4 manufactured by Cms Inc..
[15159414]
When using interplant to plan a prostate brachytherapy radiation treatment, if the user selects "adjust needle trajectory" for a retracted needle, after saving, closing and then recalling the plan, the needle shown in the planned needle definitions chart within plan view shows the needle with no retraction, while the transverse or 3d planning views still correctly show the retraction. The dose volume histograms shown in the plan view are correct for the retracted needle. If the user positions the needle using the incorrect planned needle definitions, seeds will be misplaced by the amount of the original needle retraction, resulting in the dose to the tumor not being that shown in the dvh's. There were no pts mistreated as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
[15519458]
Cms is issuing a customer advisory (b) (4) for all customers to advise them of this situation. There is no date at present for when a software resolution to the problem will be available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1937649-2008-00005 |
| MDR Report Key | 1239631 |
| Report Source | 01,05 |
| Date Received | 2008-11-18 |
| Date of Report | 2008-11-18 |
| Date of Event | 2008-10-13 |
| Date Mfgr Received | 2008-10-13 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2009-11-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL PARSONS, RAA |
| Manufacturer Street | 1145 CORPORATE LAKE DR. |
| Manufacturer City | ST. LOUIS MO 63132 |
| Manufacturer Country | US |
| Manufacturer Postal | 63132 |
| Manufacturer Phone | 3148124382 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERPLANT PROSTATE BRACHYTHERAPY RTP SYSTEM |
| Generic Name | PROSTATE RADIATION TREATMENT PLANNING S |
| Product Code | KPQ |
| Date Received | 2008-11-18 |
| Model Number | RELEASE 3.4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CMS INC. |
| Manufacturer Address | ST. LOUIS MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-18 |