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 2020-03-06 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM NS2013 manufactured by Hologic, Inc..
[182434197]
Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known. 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. If the device is returned and evaluation completed, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[182434198]
It was reported that a novasure ablation procedure was completed within the setting of the physician's office. Intracervical and paracervical block was used as a pain relief. Patient returned home following completion of the procedure with no complications noted. The patient presented a week later with high temperature and severe pain. The patient was transferred to hospital care due to suspicion of a post-operative infection. The patient's condition worsened on (b)(6) 2020 and an emergency laparotomy was performed, which discovered the presence of thermal injuries to the small bowel and fallopian tube. The patient had experienced a rupture to the small bowel, and tissue necrosis to the fallopian tube due to the thermal injuries found. A small intestine stoma operation was performed on the patient ((b)(6) 2020). The following day on (b)(6) 2020 the patient presented with extreme pain and another laparotomy was performed, no additional bowel injuries were found. The patient began to recover that same day. The physician is planning to schedule the patient for a follow up procedure to close the stoma after 3 to 6 months. No additional details available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00046 |
| MDR Report Key | 9802072 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-06 |
| 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 EA SYSTEM |
| Generic Name | UTERINE ABLATION DEVICE |
| Product Code | MNB |
| Date Received | 2020-03-06 |
| Model Number | NS2013 |
| Catalog Number | NS2013 |
| 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. Life Threatening; 3. Required No Informationntervention | 2020-03-06 |