MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION HYDROS HANDPIECE; FLUID JET REMOVAL SYSTEM

Model Number	HH1000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Just as doctor was about to do the calibration of the aquablation hand piece we realized that the device was showing blank on the screen.This was when the device was still in the patient's urethra.Device was replaced with another one and med watch report was made.No patient safety concern and no general safety concern.

• Brand Name: HYDROS HANDPIECE
• Common Device Name: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; san jose CA 95134
• MDR Report Key: 24177206
• Report Number: 24177206
• Device Sequence Number: 9578569
• Product Code: PZP
• UDI-Device Identifier: 00850055427051
• UDI-Public: (01)00850055427051
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/13/2026
• Report Date (Section F): 01/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HH1000
• Device Lot Number: 25C03802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Date Report Sent to FDA: 01/13/2026