HARMONIC ACE+7 SHEARS 5MM X 36CM

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY ON (B)(6) 2022 DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE DEVICE BECAME STUCK TO THE TISSUE AND HAD TO BE 'FORCEFULLY REMOVED CAUSING SEVERE BLEEDING'. PER THE FACILITY THE ISSUE OCCURRED DURING THE MIDDLE OF THE PROCEDURE WHILE ATTEMPTING CAUTERY ON THE CYSTIC ARTERY. ACCORDING TO THE FACILITY THE DEVICE BECAME 'STUCK TO THE TISSUE' AND WHEN THEY REMOVED THE DEVICE THERE WAS SEVERE BLEEDING WHICH REQUIRED AN ADDITIONAL DEVICE TO CONTROL AND COMPLETE THE PROCEDURE. PER THE FACILITY THE PROCEDURE WAS COMPLETED AFTER EXTENDED SURGICAL TIME AND INCREASED BLOOD LOSS, BUT THE PATIENT IS REPORTED TO BE DOING 'FINE' POST PROCEDURE. THE SAMPLE WAS RETURNED FOR EVALUATION, BUT A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE FACILITY ON (B)(6) 2022 DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE DEVICE BECAME STUCK TO THE TISSUE AND HAD TO BE 'FORCEFULLY REMOVED CAUSING SEVERE BLEEDING'.