Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.If additional relevant information is received or device 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 multiple alarms, including a high pressure alarm, were going off on the fluid management system.After alarms were resolved and cleared with the help of hologic representative and the procedure continued, the tissue sock exploded onto the floor.The pathology ended up on the floor along with fluid and blood.No additional details available at this time.
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