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.2 devices were involved in this case: 1222780-2023-00126.
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It was reported that a myosure procedure was completed successfully on april 4th, and once finished with the myosure reach,the doctor opened a novasure advanced and inserted it.When inserting the width gauge read 3/5 and the deficit was at 200ml, continuing to seat the device, the width dial read 4.5 and the deficit jumped to around 575 they went in with a scope and there was poor visualization.The doctor mentioned to the anesthesiologist that there may be a slight perforation and the procedure was aborted.No additional information is available.
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