FDA Adverse Event
Injury
Summary report: N
CYBERINFE ROBOTIC RADIOSURGERY SYSTEM
MDR report key: 3955102
·
Received July 7, 2014
Report
- Report Number
- 2950679-2014-00006
- Event Type
- Injury
- Date Received
- July 7, 2014
- Date of Event
- June 11, 2014
- Report Date
- June 11, 2014
- Manufacturer
- ACCURAY, INCORPORATED
- Product Code
- IYE
- PMA / PMN Number
- K122137
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTS THAT THERE WAS NO MALFUNCTION OF THE DEVICE. HOWEVER, THE REPORTED CONDITION OF THE PT IS AN UNEXPECTED OUTCOME. THE CUSTOMER ALSO REPORTS THAT THE PT IS CURRENTLY UNDER MEDICAL MANAGEMENT WITH SEVERAL TREATMENT OPTIONS. #(B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A PT BEING TREATED FOR DCIS (DUCTAL CARCINOMA IN SITU) ON THE CYBERKNIFE PARTIAL BREAST PHRASE I CLINICAL TRIAL AT 3750 CGY/5 FRACTIONS, DEVELOPED WHAT WAS THOUGHT TO BE CELLULITIS, FOLLOWED BY MARKED EDEMA AND BREAST FIBROSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 394950 | CYBERINFE ROBOTIC RADIOSURGERY SYSTEM | CYBERKNIFE SYSTEM | IYE | ACCURAY, INCORPORATED | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |