MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for NOVASURE ADVANCED IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM NS2013US manufactured by Hologic, Inc..
[180307336]
The surgeon had difficulty getting the ablation system to work. She was not sure if it was the device or the machine. No pt harm / injury happened, just a delay with the procedure from trying to troubleshoot the device/ machine issues. It was being used for endometrial ablation. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093064 |
| MDR Report Key | 9728652 |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-02-11 |
| Date Added to Maude | 2020-02-19 |
| 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 | 3 |
| Brand Name | NOVASURE ADVANCED IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM |
| Generic Name | DEVICE, THERMAL, ABLATION, ENDOMETRIAL |
| Product Code | MNB |
| Date Received | 2020-02-18 |
| Model Number | NS2013US |
| Catalog Number | NS2013US |
| Lot Number | 19J05RM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |