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

Catalog Number AB2000

Device Problem Suction Failure (4039)

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

Event Date 08/25/2023

Event Type  malfunction  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during the third treatment pass, the aquabeam console stopped aspirating fluid.Multiple troubleshooting steps were made to address the issue without avail.As a result, the aquablation procedure was aborted and the surgeon performed focal bladder neck cautery (fbnc) technique to complete the procedure.No adverse health consequences to the patient were reported due to this event.

Manufacturer Narrative

H.10 component code = 4755 - aquabeam console, a reusable component of the aquabeam robotic system, controls the functionality of the high-velocity waterjet delivered by the aquabeam handpiece.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

The aquabeam console was not returned for investigation because it is a reusable component, which is still being used at the user facility.Additional information received on 12-sep-2023 indicated that there was tissue caught within the tubing, resulting in the aspiration difficulties.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.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.The aspiration tubing should not be bent, kinked, or twisted at any point during the aquablation procedure.Bending, kinking, or twisting the aspiration tubing may result in inefficient fluid aspiration.The aquabeam robotic system ifu, ifu0101-00 rev e, states the following: 8.11 sterile: attach the input end of the aspiration tubing (the end without an arrow on it) to the port located on the side of the aquabeam handpiece.Pass the other end of the aspiration tubing (the end that does have an arrow) to a non-sterile technician.Caution: ensure that the input end of the aspiration tubing stays in the sterile environment to avoid minor infection(s).8.12 non-sterile: locate the peristaltic pump on the user's left side of the console (when facing the front of the console).The aspiration tube guide is adjacent to the peristaltic pump.Press the key found near the middle of the aspiration tubing into the gray slot in the tube guide, in order to activate the switch.Ensure that the key is fully inserted into the slot.Open the peristaltic pump head and place the aspiration tubing inside the pump head.Carefully close the cover while ensuring the aspiration tubing is centered within the front and back jaws.Caution: verify that the tubing joints are securely attached to the peristaltic pump and that the tubing is correctly installed.Ensure the aspiration tubing is not pinched at the jaws located in the front and back side of the peristaltic pump.Failure to verify the proper installation may result in inefficient fluid aspiration due to poorly connected or damaged tubing.8.13 non-sterile: attach the outlet end of the aspiration tubing (the end with the arrow) to the fluid outlet receptacle.Warning: the aspiration tubing should not be bent, kinked, or twisted at any point during the aquablation procedure.Bending, kinking, or twisting the aspiration tubing may result in inefficient fluid aspiration.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam console / lot number (b)(6) was performed, which confirmed that there were no nonconformances, failures, discrepancies,or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system and its associated component met all design and manufacturing specifications when released for distribution.The root cause of the reported event was unable to be established as the device was not returned for investigation.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Manufacturer Narrative

The aquabeam console was returned for investigation.Testing was unable to be performed as the aquabeam console's computer io port was observed to be crushed and damaged.However, based on the event description, the reported aspiration difficulties were found to be due to tissue blockage inside the aspiration tube which was able to be cleared and the aquabeam console was able to function as intended after the blockage was cleared.The root cause of the damaged cable port is unable to be determined.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam console / lot number 23c02579 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.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.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.·the aspiration tubing should not be bent, kinked, or twisted at any point during the aquablation procedure.Bending, kinking, or twisting the aspiration tubing may result in inefficient fluid aspiration.The aquabeam robotic system ifu, ifu0101-00 rev e, states the following: 8.11 sterile: attach the input end of the aspiration tubing (the end without an arrow on it) to the port located on the side of the aquabeam handpiece.Pass the other end of the aspiration tubing (the end that does have an arrow) to a non-sterile technician.Caution: ensure that the input end of the aspiration tubing stays in the sterile environment to avoid minor infection(s).8.12 non-sterile: locate the peristaltic pump on the user's left side of the console (when facing the front of the console).The aspiration tube guide is adjacent to the peristaltic pump.Press the key found near the middle of the aspiration tubing into the gray slot in the tube guide, in order to activate the switch.Ensure that the key is fully inserted into the slot.Open the peristaltic pump head and place the aspiration tubing inside the pump head.Carefully close the cover while ensuring the aspiration tubing is centered within the front and back jaws.Caution: verify that the tubing joints are securely attached to the peristaltic pump and that the tubing is correctly installed.Ensure the aspiration tubing is not pinched at the jaws located in the front and back side of the peristaltic pump.Failure to verify the proper installation may result in inefficient fluid aspiration due to poorly connected or damaged tubing.8.13 non-sterile: attach the outlet end of the aspiration tubing (the end with the arrow) to the fluid outlet receptacle.Warning: the aspiration tubing should not be bent, kinked, or twisted at any point during the aquablation procedure.Bending, kinking, or twisting the aspiration tubing may result in inefficient fluid aspiration.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: 17746184
• MDR Text Key: 323415646
• Report Number: 3012977056-2023-00148
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/$$720C00343/16D20200729F
• 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: 04/15/2024

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: 08/28/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 09/12/2023; 04/05/2024
• Supplement Dates FDA Received: 09/22/2023; 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2020
• 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