HARMONIC ACE+7 SHEARS W/ ADV. HEMOSTASIS
Received May 16, 2026 · Event occurred Apr 15, 2026
Report 3032391-2026-00011 · MDR key 25194832
Device
Generic name
Harmonic Ace+7 Shears 5mm X 36cm
Manufacturer
Medline RenewalCatalog number
HARH36R
Lot number
563224
Product problems
- Material Fragmentation
- Peeled/Delaminated
- Excessive Heating
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, PER STAFF IN THE ROOM, A PIECE OF PLASTIC BROKE WAS RETRIEVED. WHILE INACTIVE THE BLADE STARTED TO PEEL. THE INSTRUMENT WAS ENTIRELY TOO HOT ENTIRE SHAFT WAS TOO HOT TO EVEN TOUCH.
Additional Manufacturer Narrative
IT WAS REPORTED THAT, PER STAFF IN THE ROOM, A PIECE OF PLASTIC BROKE WAS RETRIEVED. WHILE INACTIVE THE BLADE STARTED TO PEEL. THE INSTRUMENT WAS ENTIRELY TOO HOT ENTIRE SHAFT WAS TOO HOT TO EVEN TOUCH. 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.