Device Problem
Other (for use when an appropriate device code cannot be identified) (2203)
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Patient Problems
Surgical procedure (2357); Iatrogenic Source (2498); Treatment with medication(s) (2571)
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Event Date 11/20/2012 |
Event Type
Injury
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Event Description
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It was reported by an attorney that the patient underwent a laparoscopic hysterectomy and bsoo for the treatment of uterine fibroids on (b)(6) 2012 and a morcellator was utilized.No ca was diagnosed prior to surgery.The pathology revealed endometrial adenocarcinoma.The patient has undergone treatment , including chemotherapy.
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Manufacturer Narrative
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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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Manufacturer Narrative
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Additional narrative: it was reported that the patient had a laparoscopic supracervical hysterectomy, bso, cystoscopy and enterolysis of adhesions on (b)(6) 2012 and mesh was utilized.Pathology showed endometrioid adenocarcinoma.She had a complete surgical debulking on (b)(6) 2013 and was treated with chemotherapy in (b)(6) 2015.
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Search Alerts/Recalls
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