MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-21 for NOVASURE SURESOUND 2007 NS2007US manufactured by Hologic, Inc..
[175676441]
Novasure ablation device did not pass the cavity assessment. Surgeon tried closing the cervix tighter with tenaculum. Did not pass cavity assessment second time. Surgeon tried again to adjust the device and did not pass the third time. Used a new device and passed cavity assessment on the first try. Malfunctioning equipment reported and different device utilized for procedure. Equipment removed from service and tagged per policy. This equipment is maintained by the manufacturer. The vendor will inspect the device for any malfunctions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610496 |
| MDR Report Key | 9610496 |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-09 |
| Date of Event | 2020-01-03 |
| Report Date | 2020-01-09 |
| Date Reported to FDA | 2020-01-09 |
| Date Reported to Mfgr | 2020-01-21 |
| Date Added to Maude | 2020-01-21 |
| 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 | RISK MANAGER |
| 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 SURESOUND |
| Generic Name | DEVICE, THERMAL ABLATION, ENDOMETRIAL |
| Product Code | MNB |
| Date Received | 2020-01-21 |
| Model Number | 2007 |
| Catalog Number | NS2007US |
| Lot Number | 19K29RA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 445 SIMARANO DRIVE MARLBORO MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-21 |