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

Catalog Number	HY1000T
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause of the reported event has not yet been established.Investigation by manufacturer is currently in-process.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
Event or Problem Description
A male patient underwent aquablation therapy to treat symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during the first treatment pass, the hydros robotic system displayed error e251 (z encoder speed was less than 80% of the desired speed for over 10ms).The treating surgeon tried to manually move the waterjet, but the error persisted.Due to the inability to resolve the issue, the treating surgeon decided to abort the procedure.There were no adverse health consequences for the patient as a result of this event.
Additional Manufacturer Narrative
The aquabeam handpiece (hp) was not returned for investigation.Three (3) good faith efforts were made by procept to retrieve the aquabeam hp without success.The root cause of the reported event was unable to be established as the device was not returned for investigation.A review of the device history record (dhr) for lot number 25c05421 was conducted, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the device met all design and manufacturing specifications when released for distribution.The treatment session log file were reviewed and confirmed the occurrence of error e251 (z encoder speed was less than 80% of the desired speed for over 10ms) in the treatment stage.The hp was not returned after follow ups.The application log file review confirmed the occurrence of e251 in treatment stage.Root cause is undeterminable as the issue cannot be investigated further due to unavailability of device.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• Brand Name: HYDROS ROBOTIC SYSTEM
• Common Device Name: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr; san jose, CA 95134 ; 6502327291
• MDR Report Key: 24701228
• Report Number: 3012977056-2026-00060
• Device Sequence Number: 10151918
• Product Code: PZP
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K240200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: HY1000T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male