MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-18 for ELEKTA 1049544 manufactured by Elekta.
[40938195]
Frame adapter used in gamma knife delivery was discovered to not be in the correct position but was locked. The manufacturer stated that it could not be locked if not in correct position. The frame adapter used in the procedure was a new product. The older adapters could not be locked if not in correct position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061035 |
| MDR Report Key | 5515905 |
| Date Received | 2016-03-18 |
| Date of Report | 2016-03-03 |
| Date of Event | 2016-02-02 |
| Date Added to Maude | 2016-03-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ELEKTA |
| Generic Name | FRAME ADAPTER |
| Product Code | IWB |
| Date Received | 2016-03-18 |
| Model Number | 1049544 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA |
| Manufacturer Address | ATLANTA GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-18 |