Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.The 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 unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.(b)(4).
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It was reported the physician performed a myosure procedure for uterine tissue removal on (b)(6) 2017 and the patient was discharged home.On (b)(6) 2017, the pathology report came back and stated "there were 2 spherical gray metal shiny bead like pieces".The patient is doing fine, no more bleeding and no more pain.
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