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 2020-01-16 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM NS2013 manufactured by Hologic, Inc.
[176866396]
Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known. 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 number of the disposable device not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review was unable to be conducted for the disposable device or the radio frequency controller as the identification numbers were not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[176866397]
It was reported that prior to the ablation being performed, the patient underwent a salpingectomy. When the ablation portion of the procedure began, the "device would not open beyond the red zone. " the device was removed from the patient cavity and then reseated. No resistance was felt at the fundus. The physician viewed the cavity via hysteroscope and noted "yellow tissue" at the fundus. It was noted that distention and visibility of the cavity were poor. "patient was given some unknown medication. " no device is returning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00012 |
| MDR Report Key | 9596566 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-16 |
| Date of Report | 2019-12-27 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2019-12-27 |
| Date Added to Maude | 2020-01-16 |
| 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 | KELSEA LYVER |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082636130 |
| 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 | 2020-01-16 |
| Model Number | NS2013 |
| Catalog Number | NS2013 |
| 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 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-01-16 |