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	09/16/2024
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 for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that the aquabeam robotic system generated an "e22 - motorpack error" when connecting the aquabeam handpiece to the aquabeam motorpack.The e22 error was cleared.During nozzle registration the aquabeam robotic system generated another "e22 - motorpack error".The error was again cleared.During the first treatment pass, the aquabeam robotic system generated multiple "e22 - motorpack error", "e23 - motorpack error", and "e31 - motorpack error".After troubleshooting, the first treatment pass was able to be completed.During the second treatment pass, the aquabeam robotic system generated multiple "e22 - motorpack error", "e23 - motorpack error", and "e31 - motorpack error".As a result, the treating surgeon decided to use a bipolar loop to finish the treatment.There were no adverse health consequences to the patient due to this event.
Additional Manufacturer Narrative
The aquabeam handpiece was not returned for investigation of the reported event as it was disposed of at the hospital.A replacement aquabeam handpiece was provided to the hospital as part of warranty replacement.The treatment log files were reviewed and found that the system triggered an e22 error along with an e23 error, confirming the reported event.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 aquabeam robotic system/serial number (b)(6) and the aquabeam handpiece / lot number 23c03489 was performed, which confirmed that there was one (1) non-conformance issued to this lot during the manafacturing process that could potentially be related to the reported failure.The lot was segregated and affected units were reworked and re-inspected as part of our handpiece final inspection process.Upon re-inspection, the lot met all required specifications and was deemed acceptable to be released for distribution.The current user manual um0101-00 rev.F, aquabeam robotic system user manual was reviewed and states the following: table 5: system detected errors and faults 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 drive; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech drive; san jose, CA 95134 ; 6502327291
• MDR Report Key: 20433942
• Report Number: 3012977056-2024-00237
• Device Sequence Number: 8506661
• Product Code: PZP
• UDI-Device Identifier: B614HP2000X1
• UDI-Public: +B614HP2000X1/$$723C03489/14D20250831
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: DEN170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2023
• 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