MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-21 for PRECISE TABLE * manufactured by Elekta Ltd.
[490176]
After end of treatment with the patient on the precise table, the therapist unlocked table x-y control and proceeded to manually move table top in the gun to target direction. As the table top was moving, unknown to the therapist, the patient moved the right hand from the pelvis where it was positioned for treatment and grabbed the side of the table top. The patient's middle finger was injured between the table top and the table base. The staff applied first aid and transferred the patient to the hospital for further treatment. The patient required 6 stitches to the finger.
Patient Sequence No: 1, Text Type: D, B5
[7790464]
The operator was present and was responsible for table movement. A service recommendation, for a modification kit that would reduce the severity of an injury should a patient move their hands and take hold of the side of the table is now available. As a preventive action measure these mod kits will be installed at all locations in the united states.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617016-2006-00003 |
| MDR Report Key | 739074 |
| Date Received | 2006-07-21 |
| Date of Report | 2006-07-21 |
| Date of Event | 2006-06-30 |
| Date Added to Maude | 2006-07-25 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | * |
| Manufacturer City | CRAWLEY, WEST SUSSEX |
| Manufacturer Country | UK |
| Manufacturer Phone | 293654250 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISE TABLE |
| Generic Name | * |
| Product Code | JAI |
| Date Received | 2006-07-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 726955 |
| Manufacturer | ELEKTA LTD |
| Manufacturer Address | * CRAWLEY, WEST SUSSEX UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-07-21 |