MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2016-03-15 for LEKSELL GAMMA KNIFE PERFEXION 1021187 manufactured by Elekta Instrument Ab.
[40328941]
The customer claimed different behaviours between 'new' and 'old' frame adapters. Multiple tests were performed on a stereotactic head-frame with both 'new' and 'old' frame adapters. Different behaviours were observed, where the clamping force of the 'new' frame adapter is higher than of the 'old'. The 'new' frame adapter locks onto the stereotactic head-frame, although the incorrect position is clearly observable if controlled. The 'old' frame adapter does not firmly lock onto the stereotactic frame: small movements will put the assembly apart. The clamping force of the 'old' frame adapter was dependent on the tolerances in machining and therefore small variations between the parts could occur. The current manufacture adapter, a note on the drawing allows the manufacturer to add one extra spring washer if needed to obtain better clamping force. If this modification is used by the manufacturer the clamping force will be slightly increased. Root cause: the failure is due to a combination of 3 failures: 1/ not keyed design, resulting in possibility to place the head-frame incorrectly in the frame adapter; 2/ discrepancy in clamping force between 'old' and 'new' frame adapter onto the stereotactic head frame in an incorrect position and still be able to lock the frame firmly; 3/ instructions not followed by the operator, resulting in a seemingly large deviation.
Patient Sequence No: 1, Text Type: N, H10
[40328942]
An issue was reported (2016-(b)(6)) where the frame adapter did not latched the g-frame properly. If this happens and is not corrected before the treatment starts, the dose will be delivered to the wrong position. The following was reported to the state of (b)(6) on (b)(6), 2016: "the patient was prepped for the delivery of doses of 18 and 21 gy to 14 subcentimeter brain metastases with gamma knife stereotactic radiosurgery. The frame adapter was placed on the patient's stereotactic head frame by a gamma knife trained registered nurse, supervised by authorized medical physicist [amp], and authorized user [au]. After five of the planned 14 lesions were treated, the patient was given a break in order to use the restroom and for additional medication. During this treatment break, the au and amp entered the room to release the patient from the restraining device and assist [the patient] to the rest room. It was at that point that it was discovered that the restraining device was locked, but not in the correct position. The displaced distance was measured and determined to be a maximum discrepancy of 2 cm in one plane. The amp and au applied the displacement to the treatment plan to determine which areas were treated and which were not. It was determined that a potential misadministration had occurred. The rso [radiation safety officer] was notified to discuss the course of action. Following discussions with the amp, au, the medical director, the prescribing physician and radiation safety officer, it was decided that there was a potential medical event or misadministration as defined in (b)(4). The cause of the event is uncertain at this time. The head restraining device should not have been able to be secured unless it was in the proper position. An investigation is ongoing and additional information is being sought. The patient received an unintended radiation dose to normal brain tissue, however, it was determined by the authorized user in consult with the medical physicist that little clinical effect will be demonstrated due to this inadvertent exposure. The patient, the patient's family and the patient's referring physician were informed of the event. After extensive discussions, it was agreed by all parties that the treatment would be completed to ensure that the correct dose is delivered to the remaining target areas.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612186-2016-00003 |
| MDR Report Key | 5500163 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2016-03-15 |
| Date of Report | 2016-03-11 |
| Date of Event | 2016-02-15 |
| Date Mfgr Received | 2016-02-16 |
| Device Manufacturer Date | 2009-07-01 |
| Date Added to Maude | 2016-03-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | GPMS |
| Manufacturer Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Manufacturer G1 | ELEKTA INSTRUMENT AB |
| Manufacturer Street | PO BOX 7593 |
| Manufacturer City | STOCKHOLM, SE10393 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE103 93 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL GAMMA KNIFE PERFEXION |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE |
| Product Code | IWB |
| Date Received | 2016-03-15 |
| Model Number | 1021187 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA INSTRUMENT AB |
| Manufacturer Address | PO BOX 7593 STOCKHOLM, SE10393 SW SE103 93 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-15 |