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

Catalog Number	AB2000
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
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, two handpieces of the aquabeam robotic system experienced incomplete water jet calibration, in conjunction with repeated errors: 'e22 - motorpack error' and 'e50 - console error.' despite efforts, these errors could not be cleared.A third handpiece was opened and successfully used to complete the procedure without further issues.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 returned for investigation.During functional testing, an e22 error triggered upon docking and could not be cleared, confirming the reported failure.The aquabeam handpiece was observed to have signs of fluid ingress on the sensor board and encoder wheel.The root cause is determined to be fluid ingress and the root cause source of the fluid remains underminable.A review of the device history record (dhr) for ab2000/serial number (b)(6) and aquabeam handpiece/lot number 24c04279 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.The user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.E22 ¿ motorpack error release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece.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: 21598998
• Report Number: 3012977056-2025-00081
• Device Sequence Number: 9035227
• Product Code: PZP
• UDI-Device Identifier: 00850055427037
• UDI-Public: 0100850055427037172610311024C04279
• 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): 06/12/2025

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: 02/22/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2024
• 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