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

Catalog Number AB2000

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

H.6 adverse event problem.Component code 4756: per the instructions for use, the aquabeam motorpack, a re-usable component of the aquabeam robotic system, provides power to the aquabeam handpiece by means of dc motors.Root cause of 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 Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation procedural setup, upon connecting the aquabeam motorpack to the aquabeam handpiece, the aquabeam robotic system generated an "e22 - motorpack error".A second handpiece was used, but the issue persisted.A third handpiece was used which resolved the issue.However, during the second treatment pass in the veru protection zone, the aquabeam robotic system generated an "e42 - motorpack error" message.Upon troubleshooting, the aquabeam robotic system generated multiple motorpack errors such as e31, e22, e21, and e50.As a result, the aquablation procedure was aborted.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

The aquabeam motorpack was returned for an investigation.No visual defects or anomalies were observed with the motorpack.The associated handpieces were not returned for investigation.Functional testing revealed that the motorpack functioned as expected and no problem was found.However, the log file review confirmed the reported failure modes.The root cause of the reported event is undeterminable as the motorpack worked as intended.The aquabeam robotic system's treatment logs file was reviewed, which confirmed the reported event.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam motorpack / lot number 22c04363 was conducted, which confirmed that there was one (1) non-conformance issued to this lot during the manufacturing process that could potentially be related to the reported event.The affected units within the lot were reworked to address the nonconformance.Upon re-inspection, the lot met all required specifications and was then deemed acceptable to be released for distribution per device specifications.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, was reviewed.E21 - motorpack error.Release foot pedal and click x.If error persists, replace motorpack e22 - motorpack error.Release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece.E23 - motorpack error.Release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece.E31 - motorpack error.Release foot pedal and click x.If error persists, replace handpiece.E42 - motorpack error.Release foot pedal and click x.If error persists, reconnect motorpack to console and turn off and turn on console.E50 - console error.Release foot pedal and click x.If error persists, turn off and turn on console and cpu.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
• Type of Device: 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: 18480353
• MDR Text Key: 333012599
• Report Number: 3012977056-2024-00004
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20221223F
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male