The device is not being returned; therefore, a failure analysis of the complaint device cannot be completed.
Device history record (dhr) review was conducted for the reported lot number of the disposable device.
The lot was released meeting all qa specifications.
Currently unable to establish a relationship or impact to the reported observation.
Sterile lot records were reviewed for this disposable device and were confirmed to be within specified limits.
Based on the info obtained to date, no direct correlation can be made between the reported event and the novasure system.
According to the instructions for use (ifu) other adverse events: the following adverse event could occur or have been reported in association with the use of the novasure system: infection or sepsis.
User facility reported that during a novasure endometrial ablation in 2009, the physician "had difficulty inserting the novasure device and several attempts were made prior to the device being successfully inserted into the uterine cavity".
Two days post ablation, two days later, the pt was admitted to the hosp with septicemia.
The pt "tested positive for infection.
"treatment included intravenous (iv) antibiotics: ceftriazone sodium and metronidazole (flagyl).
This pt received one dose of cetriazone sodium (iv) just prior to the novasure procedure.
The physician noticed "the pt was slow to wake up from the ga [general anesthesia] and complained about being hot and clammy prior to discharge home".
During follow-up the following month, it was revealed that the pt was discharged from the hosp two weeks prior and at this time, "the pt is doing well with no obvious ongoing issues".