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	08/19/2025
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 was notified that during aquablation therapy and while the patient was in the or under anesthesia, an error "e917 cystoscope sensor tip disconnected" occurred during angle planning.Troubleshooting steps were initiated, the customer attempted to clear the error message, reseat the cystoscope cord, and reboot the hydros robotic system, but the issue persisted.As a result of the problem, the treating surgeon converted the procedure to a transurethral resection of the prostate (turp).The patient was discharged the next day.There were no adverse health consequences to the patient due to this event.
Additional Manufacturer Narrative
The hydros handpiece was returned for investigation.The treatment log files were reviewed and e917 errors were observed; confirming the reported failure.During functional testing, the hydros handpiece could not establish a connection to the system.The root cause of the reported failure was unable to be determined.A review of the device history record (dhr) for hy1000t/serial number (b)(6) and hydros handpiece/lot number 24c05967 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 failure.The review indicated that the device met all design and manufacturing specifications when released for distribution.The hydros robotic system user manual, um0401-00-01, rev.C, was reviewed.Table 5 error messages: e917: no/intermittent connection.Reconnect component.1.Release foot pedal.2.Check status panel for source of issues.3.Reconnect or replace component as needed until status becomes green.4.Click ok to clear alert; may require realignment and replanning 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: 22994239
• Report Number: 3012977056-2025-00240
• Device Sequence Number: 9620061
• Product Code: PZP
• UDI-Device Identifier: 00850055427051
• UDI-Public: 0100850055427051172701311024C05967
• 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): 03/04/2026

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?: No
• 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): Follow-Up
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2025
• 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): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown