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 as the identification numbers were not provided by the complainant.
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It was reported that during the procedure, the physician sampled some suspected cancerous tissue."when she was done she felt the patient was bleeding heavily.She used pressure with sponge stick to try and stop the bleeding but it was not successful.She at that point called another physician into the room.She also consulted with the patients husband as they were potentially going to do a hysterectomy." ultimately, a hysterectomy was performed.Hologic representative believes the patient is recovering at home.No additional details available.
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