inforMED
MalfunctionPZP

AQUABEAM HANDPIECE

Received Sep 26, 2025 · Event occurred Sep 3, 2025

Report 23154038 · MDR key 23154038

Device

Generic name

Fluid Jet Removal System

Model number

HP2000

Catalog number

HP2000-C

Lot number

25C02058

Product problems

  • Defective Device
  • Communication or Transmission Problem

Patient

65 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PER THE AQUABEAM REPRESENTATIVE, THE AQUABEAM HANDPIECE WAS NOT REGISTERING WITH THE SYSTEM WHILE IT WAS INSIDE THE PATIENT. THERE WAS NO STIMULATION OCCURRING. THERE WAS NO HARM TO THE PATIENT.