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.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.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.3 devices were involves in this event: 1222780-2023-00021 / 1222780-2023-00022.
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It was reported that on january 10th, a novasure procedure and a myosure device was used to carefully clear some thickened endometrium at the fundus that was obstructing the opening of the 1st novasure device.There was only one attempt at ablation.A cavity test was done and passed before the deployment of the 2nd device.The ablation was only 15 seconds long before the generator stopped the ablation.Hysteroscopy was done, the doctor saw a perforation, and the decision was made to abort the ablation and convert the procedure to laparoscopy to check for additional injury to the patient.No additional information is available.
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