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	05/01/2025
Type of Reportable Event	Malfunction
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 and while the patient was in the operating room under anesthesia, the aquabeam handpiece experienced waterjet failure during the alignment process.After troubleshooting efforts, it was ultimately replaced with a new aquabeam handpiece.The procedure was then successfully completed.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
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.
Additional Manufacturer Narrative
The aquabeam handpiece was not returned for investigation.Three (3) documented good-faith email attempts were made to obtain the aquabeam handpiece, but it remains unavailable.The root cause is undeterminable due to the inability to investigate further.A review of the device history record (dhr) for lot number 24c05166r1 and ab2000/ 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.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 aquabeam ifu, sj-ifu0104-00, rev.C states the following: 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: 22065282
• Report Number: 3012977056-2025-00157
• Device Sequence Number: 8328604
• Product Code: PZP
• UDI-Device Identifier: 00850055427037
• UDI-Public: 0100850055427037172611301024C05166R1
• 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): 11/21/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2024
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male