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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It was reported that on (b)(6) 2023, a myosure procedure was performed and towards the end of the procedure the doctor was getting a global view of the cavity and noticed a hole in the lateral wall of the uterus that was not there when the procedure began.The doctor drained the bladder and checked the abdomen.The patient was discharged and went home on friday (the day of the procedure) and as of monday, the charge nurse had not heard anything more about the patient.No additional information is available.
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