MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-23 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM X1000 manufactured by Xoft, A Subsidary Of Icad.
[55919506]
No device failure was confirmed. Xoft quality assurance advised the physicist to retest the x-ray source and the x-ray shielding together. The physicist was able to reproduce the same high radiation readings without the shielding in place as detected during the patient procedure. When the physicist tested the device with the shielding in place, the radiation of the device was reduced to acceptable levels for procedure safety. Based on this test, the physicist concluded that the x-ray shield was not sufficiently placed in order to proceed with the patient treatment. A quality assurance check of the device history record found no anomalies relating to the manufacturing of the device. Subsequent correspondence with the hospital confirmed that the same controller system, x-ray source, and shielding were being used to treat other patients and that there was no reoccurrence of the initial complaint. User continued using device.
Patient Sequence No: 1, Text Type: N, H10
[55919507]
Hospital physicist overseeing the intraoperative radiation treatment (iort) for a breast cancer patient reported that he had recorded higher than normal ambient radiation readings from the xoft controller x-ray source while performing his quality assurance check. The physicist stated that he had re-arranged the x-ray shielding on the patient to reduce the amount of ambient radiation but still received higher than normal readings. A decision was made to abort the procedure and to follow-up the patient with external beam treatment. The patient sustained no reported injury. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005594788-2016-00003 |
| MDR Report Key | 5975633 |
| Date Received | 2016-09-23 |
| Date of Report | 2016-09-23 |
| Date of Event | 2016-09-01 |
| Device Manufacturer Date | 2008-07-30 |
| Date Added to Maude | 2016-09-23 |
| 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 | PHYSICIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. AL YOUNG |
| Manufacturer Street | 101 NICHOLSON LANE |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4084931541 |
| Manufacturer G1 | XOFT, A SUBSIDARY OF ICAD |
| Manufacturer Street | 101 NICHOLSON LANE |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95134 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Generic Name | CONTROLLER SYSTEM |
| Product Code | JAD |
| Date Received | 2016-09-23 |
| Model Number | X1000 |
| Catalog Number | X1000 |
| Operator | PHYSICIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, A SUBSIDARY OF ICAD |
| Manufacturer Address | 101 NICHOLSON LANE SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-23 |