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	01/28/2025
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 procedural setup, the aquabeam robotic system generated an "e827 - monitor touch screen is not available" which was unable to be cleared.The treating surgeon decided to abort the procedure due to the e827 error issue.There were no adverse health consequences to the patient due to this event.
Additional Manufacturer Narrative
The hydros tower touchscreen was returned for investigation.The reported failure of e827 error was confirmed during a live troubleshooting call held with a procept field service representative.Upon return of the hydros tower touchscreen, functional testing could not replicate the reported e827 error as the touchscreen was functioning as intended.The touchscreen was then sent to the manufacturer for in-depth analysis, which could not confirm the reported event.The root cause of the failure was unable to be determined.A review of the device history record (dhr) for hy1000-us/serial number (b)(6) was conducted.The touchscreen is a purchased device hence the manufacture date is not available.The receiving records were reviewed for lot 24a13327.It was confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported failure.The review indicated that the device met all design and manufacturing specifications when released for distribution.The hydros user manual, um0401-00 rev.B advises the customer to perform the following when e827 is encountered: full system restart needed.1.Release foot pedal, 2.On tower front panel, press and hold the power button to power off, 3.Press the power button again to restart; system will try to continue at current step if issue persists, call procept biorobotics.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: 21404960
• Report Number: 3012977056-2025-00047
• Device Sequence Number: 12815716
• Product Code: PZP
• UDI-Device Identifier: 00850055427051
• UDI-Public: 0100850055427051172504301024C04494
• 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): 05/29/2025

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 Catalogue Number: HY1000T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2024
• 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