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

Catalog Number AB2000

Device Problem Mechanical Problem (1384)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

H.11 additional 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, the aquabeam motorpack malfunctioned when plugged into the aquabeam console.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 investigation.During functional testing, the aquabeam motorpack did not engage or activate on its own as reported.The aquabeam motorpack functioned as intended.Signs of fluid ingress were observed around the aquabeam motorpack shell; however, it is unknown if this may have caused the reported failure.The root cause of the reported issue is unable to be determined as it is unknown what caused the reported issue and the aquabeam motorpack was found to be functioning as intended.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam motorpack / lot number 23c01459 was conducted, which confirmed 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.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.7.3 aquabeam motorpack.The aquabeam motorpack (figure 10), a re-usable component of the aquabeam robotic system, is designed to dock with the disposable aquabeam handpiece.The motorpack is connected to the aquabeam handpiece via a mechanical linkage.The motorpack provides power to the aquabeam handpiece by means of dc motors, which enable both rotational and longitudinal movement of the waterjet providing controlled and precise resection of the prostatic tissue in accordance with the cpu treatment plan."docking" means the electrical connectors and mechanical shafts of both lateral and radial motors in the motorpack are positively engaged with the aquabeam handpiece.Upon docking, the motorpack performs an aquabeam handpiece power-on self-test and calibration; a led on the aquabeam handpiece gives a visual indication of successful docking.The motorpack additionally has user controls consisting of two momentary switches, power increase button and power decrease button, that signal the aquabeam robotic system to increase or decrease the high-pressure pump power when pressed.These buttons can be used to make real-time pump power adjustments during treatment as required.The motorpack is connected to the console with a flexible cable that carries dc power to the motorpack as well as serial communication lines to transmit console commands to the motorpack/aquabeam handpiece assembly and to receive status and control information in return.The motorpack/aquabeam handpiece assembly is secured to the handpiece articulating arm via a magnetic strike plate on the motorpack.11.2.7 sterile: motorpack draping and docking with the aquabeam handpiece drape the motorpack with camera drape.Recommended that a nonsterile technician pass the motorpack to a sterile technician by feeding the motorpack into the opening of the drape.Form a tight seal around the recessed area where the aquabeam handpiece will be attached: pre-stretch the elastic region to reduce risk of tears when seating it in recess of the motorpack.Ensure the drape is properly seated in recess of the motorpack.Ensure the drape is not obstructing the magnetic plate on the motorpack.Caution: pull the drape back to recess of the motorpack.Warning: to avoid potential contamination of the motorpack, ensure it is draped with a new sterile drape for each procedure.Ensure the high-pressure tubing is centered and seated in the lower box.Dock the motorpack to the aquabeam handpiece: verify aquabeam handpiece nozzle position (i.E.The movement of the blue led) homes to the base of the aquabeam handpiece (fully proximal).Apply sterile tape over the connection between aquabeam handpiece and motorpack to seal it.Tape over the beige high-pressure tubing and under the black aquabeam scope.Keep the motorpack and the aquabeam handpiece assembly with the scope clamp assembly in a secure and sterile environment.Note: verify the motorpack is securely engaged to the aquabeam handpiece by attempting to pull the aquabeam handpiece off of the motorpack.The aquabeam handpiece should remain connected to the motorpack if properly engaged.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: 18708154
• MDR Text Key: 336425189
• Report Number: 3012977056-2024-00046
• Device Sequence Number: 1
• Product Code: PZP
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2023
• 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