MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-13 for NOVASURE SURESOUND * NS2007US manufactured by Hologic Inc..
[5639367]
The patient presented for diagnostic laparoscopy and uterine ablation. When the uterine ablation was completed, a laparoscopic view was taken, which showed two (2) areas of dermal penetration into the cornua of the uterus with perforation at the cornua; these were hemostatic. However, there were two areas of thermal spread on the right aspect of the rectum involving the peritoneum, approximately 2 cm in diameter. A sigmoidoscopy was performed by the general surgeon and both areas of the cautery injury were over-sewn. "all areas of concern had been imbricated". Patient was transferred to post-anesthesia care unit (pacu) and discharged home in stable condition on the same day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4696942 |
| MDR Report Key | 4696942 |
| Date Received | 2015-02-13 |
| Date of Report | 2015-02-13 |
| Date of Event | 2015-01-29 |
| Report Date | 2015-02-13 |
| Date Reported to FDA | 2015-02-13 |
| Date Reported to Mfgr | 2015-04-16 |
| Date Added to Maude | 2015-04-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVASURE SURESOUND |
| Generic Name | SOUND, UTERINE |
| Product Code | HHM |
| Date Received | 2015-02-13 |
| Model Number | * |
| Catalog Number | NS2007US |
| Lot Number | 14J08RC |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INC. |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-02-13 |