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 a procedure to remove remnants from a molar pregnancy, there were multiple alarms and errors being thrown by the fluid management system.The patient reportedly bled quite profusely, but there was no injury or intervention required to stop the bleeding.Towards the end of the procedure, the tissue trap lid fell off.No additional details available at this time.
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