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 2020-03-23 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM NS2013 manufactured by Hologic, Inc.
[184481466]
The device is not being returned therefore, a failure analysis of the complaint device cannot be completed. If additional relevant information is received or device 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
[184481467]
It was reported that during the procedure, the cavity was viewed via hysteroscope prior to the ablation. Cavity was intact. The ablation device was inserted into the patient and failed cavity integrity assessment two times. The cavity was viewed again and a perforation was seen. A laparoscopy was performed which confirmed the perforation. The physician "was going to zap and treat with ligasure" per hologic representative present during the case. No additional details available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00063 |
| MDR Report Key | 9865786 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-12-06 |
| Date Added to Maude | 2020-03-23 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 2636130 |
| 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 | 2020-03-23 |
| Model Number | NS2013 |
| Catalog Number | NS2013 |
| Lot Number | 19M06RK |
| 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; 2. Required No Informationntervention | 2020-03-23 |