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

Catalog Number	AB2000
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause of the reported event has not yet been established.Investigation by manufacturer is currently in process.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 became aware that during procedural setup, the aquabeam handpiece experienced an issue with jet alignment.Upon replacing the handpiece, the surgeon proceeded to successfully complete the procedure.This event resulted in a surgical delay of over 20 minutes.There were no adverse health consequences to the patient due to this event.
Additional Manufacturer Narrative
The aquabeam handpiece was not returned per case details provided.Log file review confirmed the reported issue, as it was observed that waterjet was not visible during the alignment step.Root cause is undeterminable as the issue cannot be investigated further.A review of the device history record (dhr) for ab2000-e/serial number (b)(6) and aquabeam handpiece/lot number 24c04462 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 failure.The review indicated that the device met all design and manufacturing specifications when released for distribution.Sj-um0104-00 rev c, aquabeam robotic system user manual, ce was reviewed and states below.Section 11.2.23 physician: align waterjet nozzle.Press the foot pedal to visualize position of waterjet.Retract trus probe if needed by using knobs on trus stepper.Waterjet needs to be visible at 3 or 9 o¿clock.Check waterjet for overlap with the green alignment guide on the cpu.Note: if the waterjet is not visible when the foot pedal is pressed, then either: if trus image shows no hyperechoic artifact or a single hyperechoic artifact, then press the foot pedal while retracting the trus stepper until the waterjet becomes visible; or if trus image shows two hyperechoic artifacts, then press foot pedal while retracting the aquabeam handpiece nozzle until the waterjet becomes visible.Retract the nozzle by holding the right arrow button on the cpu keyboard.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: 21561988
• Report Number: 3012977056-2025-00076
• Device Sequence Number: 4430482
• Product Code: PZP
• UDI-Device Identifier: 00850055427037
• UDI-Public: 0100850055427037172610311024C04462
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 04/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2024
• 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
• Patient Sex: Male