MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-06-23 for MOBETRON 1000 manufactured by Intraop Medical Corp..
[18606535]
Reportable incident that occurred in 2008 at customer site and was reported to us by our distributor. This involved the mobetron model 1000 electron linear accelerator that was set up during testing and had a failure of a docking drive screw and nut assembly, resulting in a treatment head dropping a short distance. Fortunately, no injuries were involved. Intraop medical corp. Is considering this incident a "malfunction", since a reoccurrence during an actual treatment could likely result in a death, serious injury or other significant adverse event experience. The remedial action involves either a self inspection by our customers to ensure the nut has not failed, as evidenced by brass debris/filings visible around the nut, docking drive screw and their cover, or an immediate inspection by intraop service personnel. Our customers have been verbally notified and an advisory notice has been sent alerting them of this potential problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953704-2008-00001 |
| MDR Report Key | 1064440 |
| Report Source | 06 |
| Date Received | 2008-06-23 |
| Date of Report | 2008-06-20 |
| Date of Event | 2008-06-16 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2008-06-25 |
| 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 Street | 570 DEL REY AVE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOBETRON |
| Generic Name | MOBILE ELECTRON LINEAR ACCELERATOR |
| Product Code | LHN |
| Date Received | 2008-06-23 |
| Model Number | 1000 |
| Catalog Number | 1000 |
| Lot Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1031834 |
| Manufacturer | INTRAOP MEDICAL CORP. |
| Manufacturer Address | 570 DEL REY AVE SUNNYVALE CA 94085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-23 |