MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-18 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM NS2013 manufactured by Hologic, Inc.
[181583003]
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 unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[181583004]
It was reported that upon ablation completion, the array would not retract back into the device while the device was still in the patient. "the plastic sheath rolled up. In the end they decided to cut away the plastic sheath in order to be able to remove the device. " no known injury to patient. No additional details available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00038 |
| MDR Report Key | 9721588 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2019-08-26 |
| Date Added to Maude | 2020-02-18 |
| 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 | 2020-02-18 |
| Model Number | NS2013 |
| Catalog Number | NS2013 |
| Lot Number | 19H26RZ |
| 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 | 2020-02-18 |