MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for NOVASURE ADVANCED NS2013KITUS manufactured by Hologic, Inc.
[184279982]
Machine kept giving error stating that array position was erroneous. Opened and utilized a second handpiece with out difficulty. Manufacturer response for impedance controlled endometrial ablation device, novasure advanced (per site reporter). Manufacturer provided tracking# and return shipping container. Delay in return, due to original shipping container was lost.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859635 |
| MDR Report Key | 9859635 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-01-17 |
| Report Date | 2020-02-06 |
| Date Reported to FDA | 2020-02-06 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Generic Name | DEVICE, THERMAL ABLATION, ENDOMETRIAL |
| Product Code | MNB |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-02-06 |
| Catalog Number | NS2013KITUS |
| Lot Number | 19J03RD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |