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

Catalog Number	AB2000
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
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 was notified of an issue during procedural setup, while the patient was under anesthesia in the operating room, where the aquabeam handpiece experienced jet alignment difficulties.In response, the treating surgeon opted to replace the handpiece with a new one, allowing the procedure to be successfully completed without further complications.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) good faith efforts were made by procept to retrieve the aquabeam handpiece and treatment log files without success.A review of the device history record (dhr) for ab2000-e/serial number (b)(6) and aquabeam handpiece/lot number 24c02544 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 current instruction for use sj-ifu0101-00 rev.B, aquabeam robotic system ifu, us, english was reviewed.8.30 sterile: treatment a.To begin the aquablation treatment, step on the foot pedal and gently support the beige braided tubing extending from the back of the aquabeam handpiece.Caution (for system models other than ab2000c): failure to support the beige braided tubing may result in a system fault or insufficient cutting efficacy.A.During the aquablation treatment, use [-] indicator on the motorpack to decrease power/resection depth (if needed) and use [+] to increase back to planned power.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: 21646375
• Report Number: 3012977056-2025-00099
• Device Sequence Number: 7694824
• Product Code: PZP
• UDI-Device Identifier: 00850055427037
• UDI-Public: 0100850055427037172608311024C02544
• 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): 05/08/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male