MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-04 for PLASMABLADE(TM) PS210-030S manufactured by Medtronic Advanced Energy, Llc.
[63845059]
Patient Sequence No: 1, Text Type: N, H10
[63845060]
Device would not plug into the machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6221174 |
| MDR Report Key | 6221174 |
| Date Received | 2017-01-04 |
| Date of Report | 2016-12-19 |
| Date of Event | 2016-12-02 |
| Report Date | 2016-12-19 |
| Date Reported to FDA | 2016-12-19 |
| Date Reported to Mfgr | 2016-12-19 |
| Date Added to Maude | 2017-01-04 |
| 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 | 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 | 3 |
| Brand Name | PLASMABLADE(TM) |
| Generic Name | ELECTROSURGICAL, CUTTING, COAGULATION |
| Product Code | DWG |
| Date Received | 2017-01-04 |
| Model Number | PS210-030S |
| Catalog Number | PS210-030S |
| Lot Number | 0211672068 |
| ID Number | PS210-0305 |
| Device Expiration Date | 2019-08-02 |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-04 |