MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-05-08 for INTRABEAM SYSTEM PRS 500 304534-7000-338 manufactured by Carl Zeiss Meditec Ag.
[15205293]
The site reported that during an intraoperative radiotherapy (iort) surgical procedure, they encountered the error message, "steer error", with the concomitant shut down of the intrabeam miniature therapeutic x-ray device. The staff were able to perform troubleshooting and restart the iort procedure. The problem was encountered and resolved three more times during the iort procedure. The total procedural delay was approximately 198 minutes. The prescribed dose was successfully administered to the pt. This is information for pt 1 of 2.
Patient Sequence No: 1, Text Type: D, B5
[15601063]
The manufacturer's representative inspected the intrabeam system on-site and found he could reproduce the problem when using the intrabeam miniature x-ray source (xrs) in an upside down mode. The xrs was exchanged for another and returned to the manufacturer for further evaluation. The intrabeam automatic beam centering (abc) controls the electron beam positioning to manufacturer's specifications. When the beam position exceeds tolerances, the system displays an error message and the xrs is automatically turned off. Troubleshooting and error messages are discussed in the user manual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615010-2013-00011 |
| MDR Report Key | 3113970 |
| Report Source | 01,07 |
| Date Received | 2013-05-08 |
| Date of Report | 2013-05-08 |
| Date of Event | 2013-04-15 |
| Date Mfgr Received | 2013-04-15 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2013-07-15 |
| 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 | JUDY BRIMACCOMBE |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574616 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG |
| Manufacturer Street | RUDOLF-EBER-STRASSE 11 |
| Manufacturer City | OBERKOCHEN D-73447 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-73447 |
| Single Use | 3 |
| Remedial Action | RL |
| 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 | 2013-05-08 |
| Model Number | PRS 500 |
| Catalog Number | 304534-7000-338 |
| Lot Number | NA |
| ID Number | NA |
| 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 |
| Manufacturer Address | OBERKOCHEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-08 |