HARMONIC ACE+7 SHEARS 5MM X 36CM
Received Dec 5, 2025 · Event occurred Nov 7, 2025
Report 3032391-2025-00010 · MDR key 23729858
Device
Product problems
- Break
- Break
Patient
67 YR · Male
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY, ON (B)(6) 2025, WHILE THE DOCTOR WAS USING THE INSTRUMENT DURING A LAPAROSCOPIC CASE, "THE SCRUB NURSE QUICKLY NOTED THE BLADE HAD FALLEN/BROKEN OFF THE INSTRUMENT AND LANDED IN THE ABDOMEN. SURGEON WAS ABLE TO RETRIEVE THE PIECE THROUGH A TROCAR SITE WITH A LAPAROSCOPIC GRASPING TOOL." THE FACILITY REPORTS THEY WERE "ABLE TO RETRIEVE THE BROKEN PIECE WITHOUT HARM TO THE PATIENT OR DELAY TO THE PROCEDURE." NO ADDITIONAL INFORMATION AT THIS TIME. THE PRODUCT HAS BEEN REQUESTED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. 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)2025, WHILE THE DOCTOR WAS USING THE INSTRUMENT DURING A LAPAROSCOPIC CASE, "THE SCRUB NURSE QUICKLY NOTED THE BLADE HAD FALLEN/BROKEN OFF THE INSTRUMENT AND LANDED IN THE ABDOMEN. SURGEON WAS ABLE TO RETRIEVE THE PIECE THROUGH A TROCAR SITE WITH A LAPAROSCOPIC GRASPING TOOL."