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	07/08/2026
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, during procedural setup, the patient had a high bladder neck.During insertion of the hydros handpiece, the patient experienced a bladder perforation, and a false passage was created as viewed under the cystoscope.After the incident occurred, the surgeon elected to abort the procedure.The surgeon placed an 18fr (french) catheter into the bladder over a wire.Attempts were made to obtain additional information; however, information could not be retrieved regarding the event and patient status.No malfunction of the hydros robotic system was reported.
Additional Manufacturer Narrative
A review of the device history record (dhr) was conducted for hydros robotic system 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.A review of the log files for this procedure could not be conducted as they were not provided.Three good faith efforts (gfe) 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: 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.Urethral damage causing false passage or stricture.The hydros robotic system is a reusable device; therefore, it is still currently in possession of the user facility.It was reported that during insertion of the hydros handpiece, the patient experienced a bladder perforation, and a false passage was created as viewed under the cystoscope.After the incident occurred, the surgeon elected to abort the procedure.The surgeon placed an 18fr (french) catheter into the bladder over a wire.Attempts were made to obtain additional information; however, information could not be retrieved regarding the event and patient status.Based on the review of the information provided, plus a review of the 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 ; +1(650)232-7291
• MDR Report Key: 50094007
• Report Number: 3012977056-2026-00151
• Device Sequence Number: 18721339
• Product Code: PZP
• UDI-Device Identifier: 00850055427068
• UDI-Public: 0100850055427068112511252125C05371
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/30/2026

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
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2025
• 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