MalfunctionPZP
AQUABEAM ROBOTIC SYSTEM
Received Feb 26, 2026 · Event occurred Feb 2, 2026
Report 3012977056-2026-00032 · MDR key 24455490
Device
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.