There was no specific model for the reported device used, and the letter was served to other manufacturers of morcellators.The cause of the reported event could not be confirmed.If additional information becomes available, this report will be supplemented accordingly.The filing of this report is not an admission that the device caused or contributed to the reported event.
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Olympus received a legal document which states, in 2014 a patient underwent a supracervical laparoscopic hysterectomy procedure with the use of an unidentified power morcellator in the state of (b)(6).The legal document indicates; as a result of the use of the power morcellator, the patient developed cancer and ultimately expired on (b)(6) 2017.It was also noted, that prior to undergoing surgery, the patient was not warned of the high-risk that the use of a laparoscopic power morcellator could cause the spread and recurrence cancer.
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