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 Code	Cardiac Arrest (1762)
Date of Event	05/05/2026
Type of Reportable Event	Death
Event or Problem Description
A male patient underwent aquablation therapy to treat symptomatic benign prostatic hyperplasia (bph).Procept biorobotics became aware that, post aquablation therapy, the patient experienced cardiac arrest, followed by death.The cause of death remains unknown, as the treating surgeon did not provide any further details despite multiple attempts to obtain information such as the cause of death and the relationship to the device or procedure.The date of death is also unknown.No malfunction of the aquabeam robotic system was reported.
Additional Manufacturer Narrative
The root cause of the event was unable to be determined.It was reported that patient experienced cardiac arrest, followed by death.The cause of death remains unknown, as the treating surgeon did not provide any further details despite multiple attempts to obtain information such as cause of death and relationship to the device or procedure.Shall new information becomes available in the future, then further investigation will be conducted.A review of the device history record (dhr) for ab2000-b/serial number: (b)(6) was performed, which confirmed that there were no non-conformance's, 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's treatment log file was reviewed, which confirmed no malfunctions during the aquablation procedure and indicated that the system functioned as designed.The aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, was reviewed.3.Contraindications do not use the aquabeam robotic system in patients who do not meet the indication for the system¿s intended use.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• 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: 25232235
• Report Number: 3012977056-2026-00106
• Device Sequence Number: 10238001
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D2023013C
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 05/20/2026

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: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2023
• 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: Death
• Patient Sex: Male