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	05/12/2025
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 aquablation therapy, during the jet alignment step of the procedure, the waterjet failed to activate when the surgeon pressed the foot pedal.In response, the surgeon removed the handpiece and attempted to activate the waterjet again by pressing the foot pedal; however, the waterjet still did not engage.A new handpiece was installed, but the issue persisted.Upon further troubleshooting, the waterjet functioned as expected, and the procedure could continue without further problems.The reported event caused 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 for investigation.The treatment log files were reviewed which showed a misalignment of the jet probe and trus viewing area during the initial setup, confirming the reported failure.However, proper alignment was then observed during a second attempt.The root cause of the reported event was unable to be established as the device was not returned for investigation.A review of the device history record (dhr) for ab2000 serial number (b)(6) / 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.The user manual sj-um0101-00 rev.C, aquabeam robotic system user manual, us, english was reviewed.Align waterjet nozzle by doing the following: a.Rotate the trus stepper cradle (if needed) to center the aquabeam handpiece hyperechoic artifact with the vertical yellow line.B.Press the foot pedal to visualize position of waterjet (retract trus probe if needed by using knobs on trus stepper).C.Waterjet needs to be visible at 3 or 9 o¿clock.D.If slightly off, depress the black button on the mag block (located on the handpiece articulating arm) and rotate the aquabeam handpiece axis while stepping on foot pedal to align jets to 3 and 9 o¿clock position.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: 22142394
• Report Number: 3012977056-2025-00169
• Device Sequence Number: 18200967
• 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): 08/29/2025

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: 05/13/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male