This report pertains to the first of two hologic devices used in the same procedure.See associated medwatch, mfr's report #1222780-2014-00105.It was reported that prior to a novasure endometrial ablation on (b)(6) 2014, the physician performed a hysteroscopy and noted a uterine perforation (location unk).The physician decided to continue on and to attempt the novasure procedure.Reportedly, the procedure was completed successfully and there was no medical intervention or treatment required.The pt was discharged home and is "doing ok".A hysteroscopy and dilation, (not hologic devices) were performed prior to the ablation.It is not know 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 know.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.Ref internal complaint cc# (b)(4).
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