Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known.The disposable device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known.Device history record (dhr) review was not able to be conducted for the myosure system as the identification numbers were not provided by the complainant.Reference internal complaint: (b)(4).The device is not returning.
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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# 1222780-2015-00183.It was reported during a myosure procedure for uterine tissue removal on (b)(6) 2015, there was a fluid deficit of 6500ml using saline.The patient exhibited signs of hypervolemia which included distended abdomen, tachycardia and pulmonary edema.The procedure was aborted and the patient was administered 40mg of lasix.The patient passed fluid, is ok and was discharged home.
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