(b)(4).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.It is unknown if the actual device used in this patient procedure was in fact an ethicon morcellator.The event investigation is ongoing.
|
(b)(4): it was reported that the patient underwent a davinci total laparoscopic hysterectomy, right salingo-oophorectomy and lysis of adhesions on (b)(6) 2009 and mesh was utilized.On (b)(6) 2014 she had a diagnostic laparoscopy, exploratory, laparotomy with resection of pelvic mass, excision of peritoneal nodules, omentectomy and appendectomy.Patient underwent chemotherapy treatment and was found to have liver involvement.On (b)(6) 2015 she had cholecystectomy, liver and upper abdominal debulking, pelvic tumor resection and continued chemotherapy.
|