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 2020-02-28 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM NS2013 manufactured by Hologic, Inc..
[181416275]
The device is not being returned therefore, a failure analysis of the complaint device cannot be completed. If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed. Serial number of the radio frequency controller not provided by the complainant. Device history record (dhr) review was conducted for the reported identification number of the novasure unit. 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 number was not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[181416276]
It was reported that during an endometrial ablation procedure involving a novasure device the patient experienced a bowel burn. The physician confirmed the bowel burn via laparoscopy. It was determined as a result of the laparoscopy that the device did not perforate the serosa, and as a result the unit passed the cavity integrity assessment. Surgeon performed laparotomy for resection of 2cm of intestinal tract. Patient remained hospitalized for several days. A second laparotomy was performed to flush the patient's abdomen. Patient made a quick recovery after this second intervention and was discharged from hospital care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00040 |
| MDR Report Key | 9770737 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2019-09-20 |
| Date Added to Maude | 2020-02-28 |
| 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 | 2020-02-28 |
| Model Number | NS2013 |
| Catalog Number | NS2013 |
| Lot Number | 19J20RG |
| 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 | 2020-02-28 |