MalfunctionPZP
AQUABEAM HANDPIECE
Received Nov 6, 2025 · Event occurred Sep 23, 2025
Report 23485249 · MDR key 23485249
Device
Generic name
Fluid Jet Removal System
Manufacturer
Procept Biorobotics CorporationModel number
HP2000Catalog number
HP2000-C
Lot number
25C01778
Product problems
- Therapeutic or Diagnostic Output Failure
Patient
65 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING THE PROCEDURE, THE SURGEON AND THE TECH NOTICED THAT THE AQUABLATION HANDPIECE WAS MALFUNCTIONING. THE REPS WERE PRESENT AND TRIED TO TROUBLESHOOT, TO NO AVAIL. THE DEVICE WAS REPLACED WITH A NEW HANDPIECE. NO PATIENT HARM.