inforMED
MalfunctionPZP

AQUABEAM HANDPIECE

Received Sep 17, 2024 · Event occurred Jun 4, 2024

Report 20236311 · MDR key 20236311

Device

Generic name

Fluid Jet Removal System

Model number

HP2000

Catalog number

HP2000

Lot number

24C00565

Patient

2 MO · Male

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

AQUABEAM HANDPIECE ERROR OCCURRED AT JET ALIGNMENT INSIDE PATIENT/MALFUNCTION. MANUFACTURER RESPONSE FOR AQUABEAM HANDPIECE, PROCEPT (PER SITE REPORTER). THEY PICKED UP THE PRODUCT AND WILL INITIATE A QUALITY INVESTIGATION.