MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 2015-02-17 for LEKSELL GAMMA KNIFE manufactured by Elekta Instrument Ab.
[5407729]
The customer reported that they discovered a big gap between the helmet changer (carrier) and upper bracket. They found that one or two fixing screws were broken.
Patient Sequence No: 1, Text Type: D, B5
[12888895]
The manufacturer's investigation is on-going. Further information will be provided once the investigation has concluded.
Patient Sequence No: 1, Text Type: N, H10
[35022573]
The manufacturer has completed it's investigation and found that the screw had broken due to fatigue caused by repetitive up and down movements i. E. The screws are exposed to both pressure and tensile over and over again. The root cause of the failure is likely to be a combination of several things: not able to apply required torque. Unfavourable geometry i. E. There is limited possibility for the screws to take up movements of parts in the system with low stress variation. The plate fastened to the hinge is somewhat too weak i. E. It will flex approximately a tenth of a millimeter each lift. The manufacturer does not see this as an immediate risk for either patient or operator. For two main reasons: in this case one of the two screws used for fastening broke. If the helmet changer were to fall, both screws must be broken. From the photographic inspection it was obvious that the first screw had broken due to the gap seen. Also, it is likely that the sensor indicating almost up/down will indicate that the system is not correctly set up; if both screws break, the helmet changer will fall on the trolley. There are warnings both on the machine and in the instructions for use that when exchanging helmet the operator shall be careful, stand away from the trolley and keep hands away. To prevent unplanned downtime it will be recommended to exchange the screws, bracket and plate during regular planned maintenance visits.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2015-00002 |
| MDR Report Key | 4520004 |
| Report Source | 00,01,05,06 |
| Date Received | 2015-02-17 |
| Date of Report | 2015-03-04 |
| Date Mfgr Received | 2015-01-23 |
| Date Added to Maude | 2015-03-20 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL GAMMA KNIFE |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE |
| Product Code | IWB |
| Date Received | 2015-02-17 |
| 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 | PO BOX 7593 STOCKHOLM, SE103 93 SW SE103 93 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-17 |