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 2020-03-04 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM NS2013 manufactured by Hologic, Inc.
[181974313]
As received from the field, the external sheath was crumpled. This most likely occurred during the array retraction post ablation due to the tissue increasing the external diameter of the array in relationship to the internal diameter of the external sheath. No functional testing could be performed on device due to the state the device was in. Every novasure disposable device is inspected to ensure proper device deployment and retraction prior to final release. This observation will be monitored and trended. 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
[181974314]
It was reported that during the procedure, the device was difficult to close. Upon visual inspection of the device on (b)(6) 2020, it was noted that the sheath was crumpled. No harm to patient. No additional details available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00045 |
| MDR Report Key | 9786377 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-14 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-10-10 |
| Date Added to Maude | 2020-03-04 |
| 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 | 2020-03-04 |
| Returned To Mfg | 2020-02-14 |
| Model Number | NS2013 |
| Catalog Number | NS2013 |
| Lot Number | 19K10RD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-04 |