HARMONIC ACE+7 SHEARS 5MM X 36CM
Received Nov 24, 2025 · Event occurred Nov 3, 2025
Report 3032391-2025-00008 · MDR key 23639870
Device
Product problems
- Break
- Break
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE CUSTOMER, DURING A "LAPAROSCOPIC PROCEDURE, THE WHITE PIECE INSIDE THE JAWS OF THE REPROCESSED HARMONIC CAME OFF INSIDE THE PATIENT'S ABDOMEN." THE CUSTOMER STATED, "IT LOOKED AS IF IT PARTIALLY MELTED" AND "THE PIECE WAS RETRIEVED, AND THEY OPENED A DIFFERENT HARMONIC." NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. 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 CUSTOMER, DURING A "LAPAROSCOPIC PROCEDURE, THE WHITE PIECE INSIDE THE JAWS OF THE REPROCESSED HARMONIC CAME OFF INSIDE THE PATIENT'S ABDOMEN."