MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM NS2007 manufactured by Hologic, Inc..
[185659104]
Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant. Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known. Serial number of the radio frequency controller not provided by the complainant. 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. Lot and serial numbers not provided by the complainant; therefore, the manufacture date of the disposable device and radio frequency controller is not known.
Patient Sequence No: 1, Text Type: N, H10
[185659105]
It was reported that during a novasure procedure the disposable device failed the cavity integrity assessment (cia) test, so the doctor scoped the patient and observed a perforation. The doctor was not sure if it was the scope or the device that may have caused it. The procedure was aborted and the patient was reported to be doing fine. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00067 |
| MDR Report Key | 9888296 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Model Number | NS2007 |
| Catalog Number | NS2007 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2020-03-27 |