MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-26 for INTRABEAM SYSTEM PRS 500 000001-5408-132 manufactured by Carl Zeiss Meditec Ag (site Oberkochen).
[17563474]
It was reported that multiple errors occurred during the start of the intraoperative radiation therapy (iort) treatment using the intrabeam miniature therapeutic x- ray device. After successful attempts to resolve the errors, the surgeon made the decision ot discontinue the iort treatment. At this point, 0. 15 gy of the prescribed dose of 20. 00 gy had been delivered. The total procedural delay between the first and last error messages was 51 minutes.
Patient Sequence No: 1, Text Type: D, B5
[17675943]
The mfr's rep inspected the intrabeam system and found that one of the transport locks was not released. The unreleased transport lock contributed to a misalignment of the applicator tip. Detection of tip misalignment will shut down the intrabeam system and generate an error message.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615010-2013-00003 |
| MDR Report Key | 2985873 |
| Report Source | 05,06 |
| Date Received | 2013-02-26 |
| Date of Report | 2013-02-26 |
| Date of Event | 2013-01-28 |
| Date Mfgr Received | 2013-01-28 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2013-05-06 |
| 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 | CARL ZEISS STRASSE 22 |
| Manufacturer City | OBERKOCHEN 73447 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 73447 |
| Single Use | 3 |
| Remedial Action | MA |
| 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 | 2013-02-26 |
| Model Number | PRS 500 |
| Catalog Number | 000001-5408-132 |
| 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 (SITE OBERKOCHEN) |
| Manufacturer Address | OBERKOCHEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-26 |