MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-10 for MIDAS REX DISSECTING TOOL * T12MH25L manufactured by Medtronic Powered Surgical Solutions.
[18918524]
The dissecting tool broke in two while using. Both of the pieces were retrieved and there was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4522835 |
| MDR Report Key | 4522835 |
| Date Received | 2015-02-10 |
| Date of Report | 2015-02-09 |
| Date of Event | 2015-01-29 |
| Report Date | 2015-02-09 |
| Date Reported to FDA | 2015-02-10 |
| Date Reported to Mfgr | 2015-02-18 |
| Date Added to Maude | 2015-02-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDAS REX DISSECTING TOOL |
| Generic Name | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
| Product Code | NLN |
| Date Received | 2015-02-10 |
| Model Number | * |
| Catalog Number | T12MH25L |
| Lot Number | 0209038024 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC POWERED SURGICAL SOLUTIONS |
| Manufacturer Address | 4620 NORTH BEACH STREET FORT WORTH TX 76137 US 76137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-10 |