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 2020-03-20 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM NS2007 manufactured by Hologic, Inc.
[184386688]
Device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications. 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.
Patient Sequence No: 1, Text Type: N, H10
[184386689]
It was reported that during the procedure, the physician attempted to pass cavity integrity assessment twice. The physician then utilized vaseline and gauze in an attempt to seal the cervix twice but the device would not pass cavity integrity assesment. The device was removed from the patient and reseated, it then passed assessment and the ablation was completed. After ablation was completed, a laparoscopy was performed to complete a planned salpingectomy. On laparoscopy, two areas of blanching as well as a uterine perforation were found. General surgeon noted a burn to the patient colon. Reportedly, the area of concern was removed and the rectal serosa was oversewn. No additional details available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00060 |
| MDR Report Key | 9861047 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-11-21 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| Model Number | NS2007 |
| Catalog Number | NS2007 |
| Lot Number | 19L2RT |
| 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 | 2020-03-20 |