MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-11 for INTRABEAM SYSTEM PRS 500 000001-5408-132 manufactured by Carl Zeiss Meditec Ag (site Oberkochen).
[3594546]
It was reported that multiple errors occurred during an intraoperative radiation therapy (iort) treatment using the intrabeam miniature therapeutic x-ray device. After unsuccessful attempts to resolve the errors and 45 minutes of delay, the surgeon made the decision to discontinue the iort treatment. At this point, 0. 94 gray (gy) of the prescribed dose of 20. 0 gy had been delivered.
Patient Sequence No: 1, Text Type: D, B5
[10992362]
The intrabeam miniature x-ray radiation source was sent to the manufacturer for investigation. The root cause was found to be due to failure of a printed circuit board. The iort treatment dose is part of a complex radiation therapy plan. Any remaining treatment dose can be delivered with external beam radiation therapy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615010-2013-00017 |
| MDR Report Key | 3227103 |
| Report Source | 05,06 |
| Date Received | 2013-07-11 |
| Date of Report | 2013-07-11 |
| Date of Event | 2013-06-12 |
| Date Mfgr Received | 2013-06-12 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2013-10-02 |
| 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 | JUDY BRIMACOMBE |
| Manufacturer Street | 5160 HACIENDA DR. |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574616 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG, SITE OBERKOCHEN |
| Manufacturer Street | RUDOLF-EBER-STRASSE 11 |
| Manufacturer City | OBERKOCHEN D-73447 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-73447 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRABEAM SYSTEM |
| Generic Name | SYSTEM, THERAPEUTIC, X-RAY |
| Product Code | JAD |
| Date Received | 2013-07-11 |
| Model Number | PRS 500 |
| Catalog Number | 000001-5408-132 |
| Lot Number | NA |
| ID Number | CONSOLE: 6402101028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (SITE OBERKOCHEN) |
| Manufacturer Address | OBERKOCHEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-11 |