Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known.Device history record (dhr) review was unable to be conducted for the disposable device or the radio frequency controller as the identification numbers were not provided by the complainant.Internal reference #: (b)(4).
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This is the second of two hologic reports relating to this event.Please see 1222780-2019-00222 for the second report.It was reported that prior to the endometrial ablation, a laparascopic tubal ligation was performed.The endometrial ablation procedure was performed and the physician viewed the cavity.Hologic representative noticed that it appeared the cervix was ablated and not the endometrium.The physician stated he had some confusion as to what to measure during the procedure and wanted to repeat the ablation.Hologic representative stated that this is off label use but the physician still re-inserted the device to attempt re-ablating the cavity.The physician seated the device and stated he felt no resistance but was concerned he had perforated the uterus and the procedure was aborted.A perforation was not confirmed as visualization in the cavity was difficult due to bleeding.Hologic representative states the perforation could have occurred during the sounding portion of the procedure.As far as holgic representative is aware, the patient was discharged as planned.
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