HARMONIC ACE+7 SHEARS W/ ADV. HEMOSTASIS
Received May 16, 2026 · Event occurred Apr 15, 2026
Report 3032391-2026-00012 · MDR key 25194833
Device
Generic name
Harmonic Ace+7 Shears 5mm X 36cm
Manufacturer
Medline RenewalCatalog number
HARH36R
Lot number
562173
Product problems
- Thermal Decomposition of Device
- Overheating of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT, 36HARMONIC ARE MELTING INSIDE OF PATIENTS. TWO OF THEM MELTED TODAY BACK TO BACK. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. 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
IT WAS REPORTED THAT, 36HARMONIC ARE MELTING INSIDE OF PATIENTS. TWO OF THEM MELTED TODAY BACK TO BACK.