inforMED
MalfunctionPZP

AQUABEAM HANDPIECE

Received Sep 17, 2024 · Event occurred Aug 6, 2024

Report 20236346 · MDR key 20236346

Device

Generic name

Fluid Jet Removal System

Model number

HP2000

Catalog number

HP2000

Lot number

24C01971

Patient

2 MO · Male

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

AQUABEAM DEVICE WOULD NOT ACTIVATE/TURN ON. MANUFACTURER RESPONSE FOR AQUABEAM HANDPIECE, PROCEPT (PER SITE REPORTER). THEY HAVE PICKED THE PRODUCT UP AND WILL INITIATE A QUALITY INVESTIGATION. THEY HAVE ALSO GIVEN US REPLACEMENT PRODUCT.