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	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hydros robotic system is a reusable device; therefore, it is still currently in possession of the user facility.It was reported that during aquablation therapy it was observed that the patient experienced bladder perforation after the first pass of aquablation.The surgeon stated that the event was related to the aspiration tubing being on backwards and that there was no medical intervention needed.Patient is well and has been discharged.The hydros robotic system's um lists bladder perforation as a potential risk of aquablation therapy.Based on the review of the information provided, plus a review of the treatment log files, dhr, and um, the event is considered not to be device related.A review of the device history record (dhr) was conducted for hy1000-us/serial number (b)(6) 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 system met all design and manufacturing specifications when released for distribution.The hydros robotic system's treatment log file was reviewed, which confirmed no malfunctions during the aquablation procedure and indicated that the system functioned as designed.4.2.3 warnings: procedure: avoid applying excessive compression to the prostate.Excessive compression can contribute to serious injury to the patient.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: bladder or prostate capsule perforation.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 aquablation therapy, the patient experienced a bladder perforation.The treating surgeon determined that the perforation occurred during the procedure following the initial pass, at which time the patient's bladder was overdistended, and the patient exhibited sudden bucking movement.The surgeon further stated that it was potentially related to the aspiration tubing being installed backward during setup.The surgeon also determined that no medical intervention was required.Patient is well and has been discharged.No malfunction of the hydros robotic system was reported.

• 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: 24985127
• Report Number: 3012977056-2026-00089
• Device Sequence Number: 18511703
• Product Code: PZP
• UDI-Device Identifier: 00850055427068
• UDI-Public: 010085005542706811250616
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/24/2026

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: 04/01/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male