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 NS2007 manufactured by Hologic, Inc.
[176866185]
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
[176866186]
It was reported that after small fibroids were removed from the patient uterus, the ablation began. 36 seconds into the ablation cycle, the patient had a "momentary flatline. " the physician paused the ablation. Anesthesia then informed the physician that the patient was stable again and it was okay to resume procedure. After resuming the procedure, the patient had another short reaction that lasted a few seconds. Again, the physician paused the ablation cycle until anesthesia was able to stabilize the patient. The anesthesiologist gave the "go ahead" to resume procedure one more time. The physician was able to complete the procedure at 101 seconds, with no further complications. Patient's heart rate and all oxygen saturation were stable at the end of the case. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00010 |
| MDR Report Key | 9599302 |
| 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 |
| Device Manufacturer Date | 2019-07-29 |
| 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 | NS2007 |
| Catalog Number | NS2007 |
| Lot Number | 19G29R |
| 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. Life Threatening; 2. Other; 3. Required No Informationntervention | 2020-01-16 |