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 11/30/2023

Event Type  malfunction  

Manufacturer Narrative

Component code = 4756 - aquabeam foot pedal, a reusable component of the aquabeam robotic system, used to align and activate the high-velocity waterjet during aquablation treatment.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 Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that prior to treatment inside the patient, the aquabeam foot pedal was not responding when used.Multiple troubleshooting steps were performed which resolved the issue and the user was able to proceed with setup.At the jet alignment step, the foot pedal was pressed and was not responsive.Multiple troubleshooting steps were performed; however, the issue persisted.As a result, the procedure was aborted.There were no adverse consequences to the patient due to this event.

Manufacturer Narrative

The aquabeam foot pedal was returned for investigation.During functional testing, all three buttons (priming, aspiration, and treatment) were pressed.However, the treatment pedal did not work as expected, confirming the reported issue.The root cause of the reported issue was an electronic component failure, but the exact cause was unable to be determined.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam foot pedal / lot number 19c00504 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 aquabeam robotic system user manual, um0101 rev.F, states the following: 4.3 warnings: procedure throughout the procedure, monitor the patient for unanticipated movement and immediately release the foot pedal to stop the procedure if movement is observed.Patient movement during the procedure may result in serious injury.Ensure the motorpack magnetic latch is pointing towards the black indicator.Clear any excess drape and seams off the magnet plate on the motorpack.Patient/user injury could occur with unanticipated movement of the motorpack.Active fluid evacuation/aspiration from bladder is operational during the aquablation procedure but be attentive for any occluding tissue in the aspiration tubing during the procedure.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 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: 18384814
• MDR Text Key: 331487093
• Report Number: 3012977056-2023-00246
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• 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: 06/05/2019
• 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