It was reported that on may 11th, a myosure procedure with fluent fluid management was performed, and the doctor perforated and resected a portion of the patient¿s bowel.The doctors believe that the uterus was perforated during dilation, prior to the scope or myosure device being inserted into the cavity.The perforation was not confirmed at this time but the doctor suspected there was one.The patient was kept on site for observation for 1 hr prior to being released.A few hours later, the patient was admitted to the er at a hospital closer to their home with abdominal pain.It is unknown what treatment the patient received at the er they went to.No additional information is available.
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Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.D4: 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.H3: 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.
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