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

Catalog Number	AB2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Cardiac Arrest (1762)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A male patient underwent aquablation therapy for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics (procept) became aware that during the second treatment pass, the patient had a cardiac arrest.A code blue was called to stabilize the patient.The treating surgeon successfully achieved hemostasis.It was determined that the patient had a pulmonary embolism.The patient was then taken to the intensive care unit (icu) as a result of this event.No malfunction of the aquabeam robotic system was reported.
Additional Manufacturer Narrative
The aquabeam robotic system is a reusable device; therefore it is currently in the possession of the user facility.The investigation of this event consisted of a review of the device history record (dhr), and instructions for use (ifu).A review of the device history record (dhr) for ab2000-d/serial number- (b)(6) 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 event.The review indicated that the device met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use (ifu), sj-ifu0101-00 rev c, was reviewed and states the following: 3.Contraindications do not use the aquabeam robotic system in patients who do not meet the indication for the system¿s intended use.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: embolism.The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.It was reported that a male patient underwent aquablation therapy for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics (procept) became aware that during the second pass of aquablation treatment, the patient had a cardiac arrest.A code blue was called to stabilize the patient.The treating surgeon was able to complete hemostasis safely.The patient had a pulmonary embolism.After surgery, they were transported to the icu.The patient has since been discharged from the hospital.The treating surgeon does not attribute this event to aquablation therapy.The aquabeam robotic system's instructions for use (ifu) list embolism as potential risk of aquablation therapy.Based on the event details, dhr, and ifu, the event is considered not to be device-related.

• Brand Name: AQUABEAM 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: 23994681
• Report Number: 3012977056-2026-00004
• Device Sequence Number: 18769153
• Product Code: PZP
• UDI-Device Identifier: 00850055427020
• UDI-Public: 010085005542702011230928
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: DEN170024
• 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): 02/12/2026

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
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Male