(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.The device information for use under precautions states" caution: the use of a laparoscopic tissue extraction bag is recommended for the morcellation of malignant tissue or tissue suspected of being malignant and for tissue that the physician considers to be potentially harmful when disseminated in a body cavity.As morcellation may affect endometrial pathologic examination, preoperative evaluation of the endometrium should be considered.Should malignancy be identified, use of the gynecare morcellex¿ tissue morcellator may lead to dissemination of malignant tissue.Additional: it is unknown if the actual device used in this patient procedure was in fact an ethicon morcellator.The event investigation is ongoing.
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It was reported by an attorney that the patient underwent a laparoscopic supracervical hysterectomy for the removal of uterine fibroids on (b)(6) 2012 and a morcellator was utilized.On (b)(6) 2014, the patient was diagnosed with abdominal leiomyosarcoma, the cancer metastasized, and the patient died on (b)(6) 2015.No additional information was provided.
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