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

Catalog Number	HY1000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A male patient underwent aquablation therapy to treat symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that post-aquablation, the patient experienced rectal injury.It was also noted that, despite the patient having a j-pouch, the patient understood the inherent risks and was still determined to undergo aquablation therapy.According to the treating surgeon, the procedure was successfully completed, and no additional medical intervention was required.The patient's current status and whether they have been discharged remain unknown despite multiple follow-ups.No malfunction of the hydros robotic system was reported.
Additional Manufacturer Narrative
The hydros robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The investigation of this event consisted of a review of the device history record (dhr), and user manual (um).A review of the device history record (dhr) for hy1000t/serial number (b)(6) was performed, 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.A review of the log files for this procedure could not be conducted as they were not provided.Efforts were made to obtain the log files without success.If the log files are made available in the future, then this complaint will be reopened to conduct such a review.The hydros robotic system's user manual (um) um0401-00-01, us, english, rev.C, was reviewed.4.2.3 warnings: procedure: do not use excessive force when manipulating the trus probe to avoid rectal injury.As with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include the following, some of which may lead to serious outcomes and may require intervention: rectal incontinence or rectal injury, including perforation.The hydros robotic system is a reusable device; therefore, it is still currently in possession of the user facility.It was reported that the patient experienced rectal injury.It was also noted that, despite the patient having a j-pouch, the patient understood the inherent risks and was still determined to undergo aquablation therapy.According to the treating surgeon, the procedure was successfully completed, and no additional medical intervention was required.The patient's current status and whether they have been discharged remain unknown despite multiple follow-ups.The hydros robotic system's user manual (um) lists rectal perforation and rectal injury as a potential risk of aquablation therapy.Based on the review of the information provided, dhr, and um, the event is considered not to be device related.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: 25018682
• Report Number: 3012977056-2026-00092
• Device Sequence Number: 10332865
• Product Code: PZP
• UDI-Device Identifier: 00850055427068
• UDI-Public: 010085005542706811250109
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: HY1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male