It was reported that during a myosure reach procedure on march 8th, the physician initially used alligator grasper to attempt to reveal a fibroid and perforated the uterus , later the reporter stated that he observed that the physician had perforated the fundus as well and that part of the uterine wall was resected as well.The patient was kept under observation.No other information is available.
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The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.
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