inforMED
MalfunctionPZP

HYDROS HANDPIECE

Received Dec 22, 2025 · Event occurred Nov 5, 2025

Report 23862818 · MDR key 23862818

Device

Generic name

Fluid Jet Removal System

Model number

HH1000

Lot number

25C03671

Product problems

  • Display or Visual Feedback Problem
  • Material Integrity Problem

Patient

72 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WHILE THE DEVICE WAS INSIDE PT AND DR WAS CALIBRATING AND READY TO START TREATMENT, THE IMAGE WENT OUT ON SCREEN DR REMOVED FAULTY HAND PIECE FROM PT . NEW HYDROS HANDPIECE WAS PROVIDED AND USED FOR THE CASE .SURGERY THEN PERFORMED SUCCESSFULLY.