inforMED
MalfunctionPZP

AQUABEAM ROBOTIC SYSTEM

Received Feb 26, 2026 · Event occurred Feb 2, 2026

Report 3012977056-2026-00032 · MDR key 24455490

Device

Generic name

Fluid Jet Removal System

Catalog number

AB2000

Product problems

  • Connection Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT WHILE THE CUSTOMER WAS SETTING UP, THE ULTRASOUND IMAGE DID NOT APPEAR ON THE CPU, AND THERE WAS NO TRUS SIGNAL. THE CUSTOMER ATTEMPTED TO RESEAT THE CABLE CONNECTION, POWER-CYCLE THE SYSTEM, AND SWAP THE TRUS PROBE, BUT THE ISSUE PERSISTED. AS A RESULT OF THIS ISSUE, THE PROCEDURE WAS CONVERTED TO A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.