MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2016-04-15 for INTRABEAM SYSTEM PRS 500 304534-0000-500 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[42849084]
Narrative: the manufacturer evaluated the returned intrabeam system. The root cause was found to be microparticles inside the vacuum electron ray tube of the x-ray source (xrs) causing this problem after almost 10 years of use. Design, manufacturing and cleaning of the electron ray vacuum tube are industry state of the art. The xrs passed several testing cycles during the assembly process. Another verification step is the regular customer sqa check prior to each iort. In this case, the error occurred after the healthcare professional paused the iort treatment and wanted to restart iort treatment. Standard treatment plans can include additional follow-up radiation therapy. However, due to the patient's current comorbidity, a follow-up radiation treatment to compensate for the underdose was not possible at this time.
Patient Sequence No: 1, Text Type: N, H10
[42849105]
The (b)(6) health authority informed the manufacturer: the intrabeam system was used for an interoperative radiation treatment (iort) on a patient after the surgical part of the tumor removal was completed. An error message appeared on the intrabeam system after the nurse paused the iort treatment. The healthcare provider tried to troubleshoot the problem with a zeiss technician and it was determined that the problem could not be resolved. At this time, 50% of the planned radiation dosage were delivered. Currently, the patient cannot continue with further iort or standard external radiation treatment due to comorbidity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2016-00001 |
| MDR Report Key | 5583103 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2016-04-15 |
| Date of Report | 2016-04-15 |
| Date of Event | 2016-02-09 |
| Date Mfgr Received | 2016-03-17 |
| Date Added to Maude | 2016-04-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILLIAM GUSTAFSON |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574689 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Street | RUDOLF-EBER-STRASSE 11 |
| Manufacturer City | OBERKOCHEN, BADEN-WUERTTEMBERG 73447 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 73447 |
| Single Use | 3 |
| Remedial Action | IN |
| 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 | 2016-04-15 |
| Returned To Mfg | 2016-04-06 |
| Model Number | PRS 500 |
| Catalog Number | 304534-0000-500 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Address | RUDOLF-EBER-STRASSE 11 OBERKOCHEN, BADEN-WUERTTEMBERG 73447 GM 73447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-15 |