MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2014-03-11 for LEKSELL GAMMA KNIFE 4C manufactured by Elekta Instrument Ab.
[4340960]
It was reported that a patient was stuck in a position 40-50 cm from "couch out" position with the shielding doors open. Since the door to the treatment room was locked and the operator did not know how to enter the room, the patient was stuck in this position for about 11 minutes. According to the customer the unwanted dose was 800 microsv to the patient (chest) and 30 microsv to the operator when moving the couch out.
Patient Sequence No: 1, Text Type: D, B5
[11701219]
The manufacturer's investigation is on-going. Elekta will provide further information when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[34454015]
The reason that the couch stopped is not known and the reason for the long delay (11 minutes) before the shielding doors could be closed is considered to be lack of training of hospital personnel to by-pass a device, handling the locking of the treatment room door when the shielding doors are open. The area outside the door to the treatment room is not restricted and therefore an electrically maneuvered physical lock on the door has been installed. The circuit breaker contains a bypass function which was working as intended during the incident. The operator however, was not aware of this bypass function. At present, all japanese sites are equipped with a circuit breaker on the door, with the function to lock the treatment room door during treatment/radiation. This equipped will be removed from japanese sites. This equipment is not installed at us sites. The unwanted radiation field exposing the patient in the position the patient was held in, is low as compared to the unwanted field exposing the patient in the treatment position. The estimated dose contribution from the incident, ~ 1msv to the chest, to the total unwanted dose the patient received during the entire treatment is therefore considered to be low. The estimated dose to the operator, 30 microsv, is not significant for a radiation worker. The root cause is considered to be the presence of the device handling the locking of the treatment room door, as well as lack of proper training of personnel by the hospital. This is the manufacturer's final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2014-00001 |
| MDR Report Key | 3672506 |
| Report Source | 00,05,06 |
| Date Received | 2014-03-11 |
| Date of Report | 2014-05-07 |
| Date of Event | 2014-02-13 |
| Date Mfgr Received | 2014-02-13 |
| Date Added to Maude | 2014-05-15 |
| 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 | 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL GAMMA KNIFE 4C |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE |
| Product Code | IWB |
| Date Received | 2014-03-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA INSTRUMENT AB |
| Manufacturer Address | P.O. BOX 7593 STOCKHOLM, 103-93 SW 103-93 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-11 |