Device Problem
Other (for use when an appropriate device code cannot be identified) (2203)
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Patient Problem
Other (for use when an appropriate patient code cannot be identified) (2200)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a gynecological procedure on an unknown date and an unknown mesh was implanted.It was reported that the patient experienced unspecified adverse events.No additional information has been provided.
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Manufacturer Narrative
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(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.
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Manufacturer Narrative
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It was reported that she had a total laparoscopic hysterectomy on (b)(6) 2010 and was diagnosed with pathology leiomyosarcoma on unk date.On (b)(6) 2010 she had a davinci bsoo with bilateral pelvic, periaortic lymphadenectomy, lysis of adhesions and peritoneal biopsies.
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Search Alerts/Recalls
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