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 2010-01-21 for LEKSELL GAMMA KNIFE 130125 manufactured by Elekta Instrument Ab.
[18583887]
Customer states that while removing a quick fixation screw after a gamma knife treatment, the screw separated and one portion attached to the pt's skull while the other part did not. Customer states that the portion attached to the pt was easily removed with no injury to the pt. Customer reports that on closer examination of the screw, a crack was observed as well as in a few of the other screws in their set.
Patient Sequence No: 1, Text Type: D, B5
[18689051]
An important notice technical note, "quick fixation screw tips" had been provided and received by this site in 2008 to give further info about the bio-compatibility of the screw tips and to let them know about a new warning which was added to the instructions for use for the product. This warning is intended to remind all users of the need to conduct a close visual inspection of the quick fixation screws prior to use and again once they have been removed from the pt. All of the materials used in the quick fixation screws have been checked and verified as bio-compatible for 24 hours according to iso. It is known that the metal alloy used to manufacture the screw tips is sensitive to handling errors, such as dropping. There have been no similar incidents of this nature reported, though the quick fixation screws mounted solely in gamma knife procedures over the past 10 years. There is no evidence that this event is related to a design problem or device malfunction. Due to the isolated nature of this incident and lack of evidence to the contrary, the root cause of this event has been classified as user handling error and the device worked according to the specs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2010-00001 |
| MDR Report Key | 1585669 |
| Report Source | 00,05,06 |
| Date Received | 2010-01-21 |
| Date of Event | 2010-01-20 |
| Date Mfgr Received | 2010-01-03 |
| Date Added to Maude | 2010-01-28 |
| 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 City | STOCKHOLM |
| Manufacturer Country | SW |
| Manufacturer Phone | 293654250 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL GAMMA KNIFE |
| Generic Name | RADIATION THERAPY |
| Product Code | IWB |
| Date Received | 2010-01-21 |
| Catalog Number | 130125 |
| 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 | STOCKHOLM SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-01-21 |