NOVASURWE IMPEDANCE CONTROLLED EA SYSTEM Adverse Event — Injury (MDR 1222780-2008-00012)
NOVASURWE IMPEDANCE CONTROLLED EA SYSTEM Adverse Event — Injury (MDR 1222780-2008-00012) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: NOVASURWE IMPEDANCE CONTROLLED EA SYSTEM; Generic name: RADIO FREQUENCY ENDOMETRIAL ABLATION; Manufacturer: CYTYC SURGICAL PRODUCTS.
| Device | NOVASURWE IMPEDANCE CONTROLLED EA SYSTEM |
|---|---|
| Generic name | RADIO FREQUENCY ENDOMETRIAL ABLATION |
| Manufacturer | CYTYC SURGICAL PRODUCTS |
| Report number | 1222780-2008-00012 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-21 |
| Report source | Health Professional, User facility |
| Narrative | USER FACILITY REPORTED UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS WITH TWO DISPOSABLE NOVASURE DEVICES. ON HYSTEROSCOPY A UTERINE PERFORATION WAS SEEN AT THE FUNDUS. A LAPAROSCOPY WAS PERFORMED AND THE PERFORATION WAS CAUTERIZED. THE PT WAS DISCHARGED HOME FOLLOWING THE PROCEDURE. IN 2008, THE PHYSICIAN REPORTED THE PT HAS BEEN SEEN ON FOLLOW-UP AND IS DOING FINE. |
| Source | openFDA MAUDE (device adverse events) |
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