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 2020-02-19 for NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM NS2007 manufactured by Hologic, Inc..
[180024395]
Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date and udi number is not known. Serial number of the radio frequency controller not provided by the complainant. The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed. Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant. If the device is returned and evaluation completed, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[180024396]
It was reported that following the successful completion of a novasure ablation procedure, the physician had perforated the uterus while attempting to remove the device. The physician stated that they knew this "was not a device issue as they had perforated the uterus". The physician reported that they "felt the perforation happen post procedure when they were removing the device. They had felt that they had pushed the device in too far after unlocking the device and believe this is when the perforation happened. " the patient had presented with post ablation pain and a diagnostic laparoscopy was performed by the physician, a uterine perforation was confirmed at the fundus, a thermal injury to the small bowel was also observed. The patient was transferred to hospital for post-op care, "patient is doing well in post-op care". No additional details at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00037 |
| MDR Report Key | 9729043 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-02-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2020-02-19 |
| Model Number | NS2007 |
| Catalog Number | NS2007 |
| Lot Number | UNKNOWN |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-02-19 |