MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2013-02-21 for PRECISE TABLE manufactured by Elekta Ltd..
[3132146]
Inadvertent column rotation can cause lateral shift. It has been found that the precise table column rotation can be positioned a fraction of a degree off zero and the brake applied, leaving the table slightly rotated. The treatment room monitors (trms) and other displays would show 8 degrees as the actual value, and all logs (audit trail) would also show the actual value as 0 degrees (all logs and displays of column rotation are shown as whole degrees). The angular rotation is of minor consequence but the resulting lateral translation could be several millimetres at isocentre which becomes particularly important for highly precise treatments. To move the column away from a zero position requires considerable (>200n) force - but to move it from a slightly non-zero position back to zero requires a very small force and could occur accidentally, between the time when the patient is set up for treatment and when the therapeutic radiation is delivered. In such a case the operator would have no indication that a displacement occurred. No injury or mistreatment has been reported to elekta.
Patient Sequence No: 1, Text Type: D, B5
[10579029]
The investigation into the incident is on-going at this time. Once the investigation is complete, elekta will forward additional information to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617016-2013-00002 |
| MDR Report Key | 2979978 |
| Report Source | 00,07 |
| Date Received | 2013-02-21 |
| Date of Report | 2013-02-21 |
| Date of Event | 2013-01-24 |
| Date Added to Maude | 2013-03-20 |
| 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 | LINAC HOUSE, FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISE TABLE |
| Generic Name | TABLE, RADIATION THERAPY, EX-RAY POWERED |
| Product Code | JAI |
| Date Received | 2013-02-21 |
| Model Number | NA |
| Lot Number | HW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA LTD. |
| Manufacturer Address | LINAC HOUSE, FLEMING WAY CRAWLEY, WEST SUSSEX RH109RR UK RH10 9RR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-21 |