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.Reference internal complaint (b)(4).
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It was reported the physician performed a myosure procedure for uterine tissue removal on (b)(6) 2017, and was "experiencing poor visibility as the lens kept fogging up".The physician then removed the hysteroscope to "wipe it and when doing so the patient started bleeding profusely".The physician noticed the patient's "vessel was perforated" and attempted to stitch the patient, but "could not locate a needle driver in a timely manner so the patient was put on an iv and sent to the er by ambulance where the doctor would stitch her".On (b)(6) 2017, it was reported the patient was stitched.The patient received a couple units of blood.The patient was admitted into the hospital on (b)(6) 2017 and discharged on (b)(6) 2017.The patient has not had any complaints since.
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