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 involved in this event reported under: 1222780-2022-00248 / 1222780-2022-00249.
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It was reported that on (b)(6) 2022, a novasure procedure was performed and they noticed deficit climbing.After the novasure procedure, they did a laparoscopy and did notice a perforation.Checked bowel, and it was fine.During the laparoscopy, they noticed several fibroids and a good portion was missed by the ablation.The patient is fine, with no further injury.No additional information available.Additional information: it was a uterus perforation and the patient did not require additional intervention.A myosure procedure was performed previous the novasure ablation and a hysteroscope was used as well.
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