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

Model Number AB2000

Device Problems Failure to Power Up (1476); Visual Prompts will not Clear (2281)

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

Event Date 05/05/2023

Event Type  malfunction  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation procedure, the aquabeam robotic system generated "no console power" error message, which was unable to be cleared despite multiple troubleshooting steps taken in efforts to resolve the issue.As a result of this event, the aquablation procedure was aborted.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

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.

Manufacturer Narrative

A review of the device history record (dhr) ab2000-b/ serial number (b)(6), and aquabeam console with lot number 20c00003 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 system met all design and manufacturing specifications when released for distribution.

Manufacturer Narrative

Adverse event problem component code (b)(4) : 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.The aquabeam console was returned for investigation of the reported event.Visual inspection and the functional testing of the returned console did not reveal any anomalies.However, when the console was tested with the associated motorpack, the console powered down, confirming the reported event.No problem was found with the console, but additional analysis found excessive fluid ingress that caused a permanent short on the motorpack, forcing the console to power down when connected to this motorpack.A review of the device history record (dhr) (b)(4) / serial number (b)(6) , and aquabeam console with lot number 20c00003 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 lot passed all final inspections and was released successfully per device specifications.The aquabeam robotic system's instructions for use (ifu), ifu0101, rev.E, states the following: 4.2.Warnings: procedure setup the roll stand ac power cord/cable is the primary component that disconnects the power source of the aquabeam robotic system and should not be positioned obstructing access to the ac power cord and mains/wall outlet.The aquabeam robotic system's user manual (um), um0101, rev.C, states the following: the console is mounted on the roll stand, which is then locked in place to prevent movement during the procedure.It is connected to the roll stand transformer with a medical-grade grounded power cord.It is connected to the cpu via a usb cable and connected to the motorpack and foot pedal through custom cables.The root cause of the reported event is determined to be design-related, as the fluid entered was likely due to the cracking of the motorpack shells.Complaint data is monitored and trended as part of procept's quality management system; shall a trend arise for this failure mode, then further actions will be considered.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; 900 island drive; suite 101; redwood city CA 94065
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065 ; 6502327291
• MDR Report Key: 16946186
• MDR Text Key: 315696016
• Report Number: 3012977056-2023-00079
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20200424C
• 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,Followup
• Report Date: 08/18/2023

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
• Device Operator: Health Professional
• Device Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 06/30/2023; 08/17/2023
• Supplement Dates FDA Received: 07/24/2023; 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2022
• 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