MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-29 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM 110 XP1100 manufactured by Xoft, Inc..
[20739468]
During intra-operative radiation treatment (iort) of the breast, the operator could not calibrate the pullback force sensor of the axxent electronic brachytherapy system. The treatment could not be completed. The root cause of the issue was determined to be due to operator miscue of the axxent electronic brachytherapy system. The operator had completely loosened the arm joint of the system and caught the arm cable within the joint, damaging the cable and resulting in the failure of the pullback force sensor noted above. The pt will be completing her treatment through other radiation treatment methods. The incident did not result in a pt injury.
Patient Sequence No: 1, Text Type: D, B5
[20971405]
The root cause of the issue was determined to be due to operator misuse of the axxent electronic brachytherapy system. The operator had completely loosened the arm joint of the system and caught the arm cable within the joint, damaging the cable and resulting in the failure of the pullback force sensor noted above. The pt will be completing her treatment through other radiation treatment methods. The incident did not result in a pt injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005594788-2011-00029 |
| MDR Report Key | 2197026 |
| Report Source | 05,06 |
| Date Received | 2011-07-29 |
| Date of Report | 2011-07-26 |
| Date of Event | 2011-07-11 |
| Date Mfgr Received | 2011-07-11 |
| Device Manufacturer Date | 2011-02-01 |
| Date Added to Maude | 2012-06-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE LIN |
| Manufacturer Street | 345 POTRERO AVE. |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 4084192341 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Generic Name | X-RAY RADIATION THERAPY SYSTEM |
| Product Code | JAD |
| Date Received | 2011-07-29 |
| Returned To Mfg | 2011-07-19 |
| Model Number | 110 |
| Catalog Number | XP1100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, INC. |
| Manufacturer Address | 345 POTRERO AVE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-29 |