inforMED
MalfunctionFEO

SHOCKPULSE-SE LITHOTRIPSY SYSTEM

Received Jul 27, 2026 · Event occurred Jul 2, 2026

Report 3011050570-2026-00765 · MDR key 50039252

Device

Generic name

Lithotriptor, Ultrasonic

Manufacturer

Gyrus Acmi, Inc.

Model number

SPL-S

Product problems

  • Break
  • Detachment of Device or Device Component

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions