Note: this report pertains to the second of two hologic devices used in the same procedure.See associated medwatch, mfr's report# 1222780-2014-00186.It was reported that during a novasure endometrial ablation on (b)(6) 2014, the physician received several unsuccessful cavity integrity assessment (cia) tests.The physician then performed a hysteroscopy and a laparoscopy and a uterine "perforation was visualized, posterior midline".The physician "packed the perforation with hemostatic gauze" and "the pt was discharged home one hour after the procedure".A hysteroscopy and dilatation (not hologic devices) were 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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Lot number of the suresound not provided by the complainant, therefore, the expiration date is not known.The suresound is not being returned therefore, a failure analysis of the complaint device can not be completed.Lot number of the suresound not provided by the complainant, therefore, the mfr date is not known.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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