MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2016-10-19 for PRECISE TREATMENT TABLE manufactured by Elekta Ltd.
[57805030]
A hospital therapist sustained an injury during a manual move of the patient support system whist a patient was loaded. The therapist's fingertip was severed when it was caught between the two end stops on the table tops longitudinal linear bearing. Although the injured user in this case may not regrow their finger nail, generally a full recovery shall be assumed with no long term effect. Finger traps are only a concern during table movement. The risk of injury for a patient is less than the risk to the clinical user as the patient is less exposed to the hazard and shall be observed by the clinician. The clinician will also be overseeing the patient during any table shifts. It is recommended to use motor driven shifts and warnings are provided in the instructions for use manual: warning 4. 5: do not use asu until you make sure that there are no objects or persons in the path of movement. Be very careful if you move more than one piece of equipment at a time. If you ignore this warning, you can cause serious injury and damage to the equipment. Warning 4. 7: do not let the patient get on the treatment table, or start treatment, before the table top is latched correctly, and the lamps in the brake release buttons are on. If you ignore this warning, you can cause serious injury. Warning 4. 8: do not let the patient move off the treatment table, or move it in the longitudinal or lateral direction, until you make sure that the patient does not catch their fingers or body parts in the path of movement. If you ignore this warning, you can cause serious injury and damage to the equipment. Risk assessed as moderate (acceptable harm).
Patient Sequence No: 1, Text Type: N, H10
[57805031]
One of the customer therapists injured her finger while using the manual longitudinal movement on the treatment table to position the patient for treatment. She injured the top part of her finger when the two longitudinal bearings collided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617016-2016-00007 |
| MDR Report Key | 6039440 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2016-10-19 |
| Date of Report | 2016-10-19 |
| Date of Event | 2016-09-21 |
| Date Mfgr Received | 2016-09-21 |
| Date Added to Maude | 2016-10-19 |
| 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 | PHYSICIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PMS |
| Manufacturer Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISE TREATMENT TABLE |
| Generic Name | COUCH, RADIATION THERAPY, POWERED |
| Product Code | JAI |
| Date Received | 2016-10-19 |
| Operator | RADIOLOGIC TECHNOLOGIST |
| 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 | 1. Other | 2016-10-19 |