It was reported by an attorney that the patient underwent a surgical procedure in (b)(6) 2012 and a power morcellator was used, concurrently with a hysterectomy and/or a fibroidectomy.It was reported that prior to the surgery, there was no evidence that the patient had disseminated or metastatic cancer.The patient was informed that she had a cancerous tumor, in or about (b)(6) 2013, the patient was diagnosed with leiomyosarcoma, at an advanced stage.The patient died on an undisclosed date.No additional information was provided.
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(b)(4).Conclusion: 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.
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