MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-14 for NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM NS2013US manufactured by Hologic, Inc..
[180761731]
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. 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 controller as the identification numbers were not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[180761732]
It was reported that following the completion of a novasure ablation procedure, the patient cavity was viewed via hysteroscopy and two white areas were seen on the fundus. The physician then decided to perform a laparoscopy and discovered two blanched areas on the exterior surface of the uterus. There were no signs of perforation, per the physician. At this time it is unknown if there was a thermal injury to the bowel. No additional information available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00031 |
| MDR Report Key | 9711171 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-14 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2019-10-10 |
| Date Added to Maude | 2020-02-14 |
| 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 | 2020-02-14 |
| Model Number | NS2013US |
| Catalog Number | NS2013US |
| Lot Number | 19K07R |
| 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 | 2020-02-14 |