MalfunctionPZP
HYDROS HANDPIECE
Received Jun 5, 2026 · Event occurred May 29, 2026
Report 25408489 · MDR key 25408489
Device
Generic name
Fluid Jet Removal System
Manufacturer
Procept Biorobotics CorporationModel number
HH1000Catalog number
HH1000
Lot number
26C00809
Patient
74 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WHEN PERFORMING THE CASE THE SURGEON INSERTED THE HYDROS HANDPIECE .WE HAD ISSUES ON AQUABLATION ROBOT SCREEN. THE IMAGE WAS DISTORTED WITH MULTIPLE GRAY/ WHITE BANDS. THE THERAPY WAS STILL NOT STARTED WHEN THIS HAPPENED. THE REPS UNPLUGGED THE HANDPIECE FROM THE AQUABLATION ROBOT. THIS DID NOT FIX THE ISSUE. THE REPS THEN RESTARTED THE AQUABLATION ROBOT.OPENED A NEW HANDPICE TO THE STERILE FIELD. DOCTOR REPLACED THE HANDPIECE AND IT WAS WORKING. PROCEDURE WAS COMPLETED WITH NO ISSUES.