MalfunctionNLQ
HARMONIC ACE+7 SHEARS W/ ADV. HEMOSTASIS
Received May 20, 2026 · Event occurred Apr 20, 2026
Report 3032391-2026-00018 · MDR key 25236649
Device
Generic name
Harmonic Ace+7 Shears 5mm X 36cm
Manufacturer
Medline RenewalCatalog number
HARH36RH
Lot number
528129
Product problems
- Failure to Fire
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT, HARMONIC SCALPELS NOT FIRING CORRECTLY. 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 IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.
Description of Event or Problem
IT WAS REPORTED THAT, HARMONIC SCALPELS NOT FIRING CORRECTLY.