MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-06 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM NS2013 manufactured by Hologic, Inc..
[182702064]
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed. If the device is returned and evaluation completed, a supplemental medwatch will be filed. Device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications.
Patient Sequence No: 1, Text Type: N, H10
[182702065]
It was reported that during a novasure procedure the physician observed a hole in the ablation array after the ablation was completed. The caller is unaware of any patient injury or negative impact to patient health. The caller did not confirm if there were any fibers within the patient. No additional details available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00044 |
| MDR Report Key | 9801925 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-08-07 |
| Date Added to Maude | 2020-03-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. DAVID RAMSAY |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 2638713 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVASURE IMPEDANCE CONTROLLED EA SYSTEM |
| Generic Name | UTERINE ABLATION DEVICE |
| Product Code | MNB |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-03-10 |
| Model Number | NS2013 |
| Catalog Number | NS2013 |
| Lot Number | 19E29RB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |