The suresound is not being returned therefore, a failure analysis of the complaint device can not be completed.Device history record (dhr) review could not be conducted for the suresound as a lot number was not provided by the complainant.According to the instructions for use (ifu) adverse events: potential adverse events include, but are not limited to perforation of the uterine wall.(b)(4).
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Note: this report pertains to the first of two hologic devices used in the same procedure.See associated medwatch, manufacturer's report# 1222780-2016-00259.It was reported the physician performed a novasure endometrial ablation on (b)(6) 2016.The physician received several unsuccessful cavity integrity assessment (cia) tests using two disposable devices.The physician performed a laparoscopy and noted a perforation.On (b)(6) 2016, it was reported the patient was admitted into the hospital and discharged after two days.It is unknown if intervention was required.The patient returned to the office for follow up and is "doing well." dilatation (not a hologic device) was performed prior to the attempted ablation.It is not known when this perforation occurred or what instrument may have been the cause.
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