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 2020-03-17 for NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM NS2013 manufactured by Hologic, Inc..
[183756618]
Upon visual inspection of the returned device, a hole was observed on the bottom side of the array near the proximal array end. This was most likely caused by excessive longitudinal retraction force exerted on the array after the procedure, resulting in abrasion of the array against the external sheath distal tip. An indent was found in the sheath where the array got caught and distorted it. As this damage presumably occurred post-ablation, the device ablation profile would not be impacted. 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. Device history record (dhr) review was unable to be conducted for the radio frequency control unit as the serial numbers were not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[183756619]
It was reported that following a successful endometrial ablation procedure involving a novasure device, the physician observed a piece of the array fabric was missing from the novasure unit and assumed it to be in the patient cavity. The doctor did not go back in via hysteroscopy to confirm and did not attempt to remove anything. It is not known if device array was inspected prior to use, total ablation time and cavity measurement information was not available. Patient was discharged the same day as the procedure ((b)(6) 2020)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00028 |
| MDR Report Key | 9842697 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2019-10-10 |
| Date Added to Maude | 2020-03-17 |
| 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 | MR. DAVID RAMSAY |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 2638713 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM |
| Generic Name | UTERINE ABLATION DEVICE |
| Product Code | MNB |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-02-24 |
| Model Number | NS2013 |
| Catalog Number | NS2013 |
| Lot Number | 19K10RK |
| Device Expiration Date | 2019-10-10 |
| 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 | 2020-03-17 |