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 2011-07-20 for LIKSELL GAMMA KNIFE 130125 manufactured by Elekta Instrument Ab.
[2265041]
While cleaning pins after taking the stereotactic frame off the pt's head, the doctor noticed that the hard metal tip of one pin was chipped. The doctor was notified and he ordered a stat x-ray. The x-ray verified the missing piece of metal deposited under the skin on the skull bone at the right posterior pin site.
Patient Sequence No: 1, Text Type: D, B5
[9259832]
This mdr is based on the uf/importer report: (b)(4). The investigation into this situation is ongoing at this time. Once the investigation is completed, more details and a conclusion will be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2011-00003 |
| MDR Report Key | 2216960 |
| Report Source | 00,05,06 |
| Date Received | 2011-07-20 |
| Date of Report | 2011-07-19 |
| Date of Event | 2011-05-25 |
| Date Mfgr Received | 2011-06-21 |
| Date Added to Maude | 2011-08-25 |
| 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 City | STOCKHOLM |
| Manufacturer Country | SW |
| Manufacturer Phone | 293654250 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIKSELL GAMMA KNIFE |
| Generic Name | RADIATION THERAPY |
| Product Code | IWB |
| Date Received | 2011-07-20 |
| Catalog Number | 130125 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-07-20 |