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

Model Number AB2000

Device Problem Suction Failure (4039)

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

Event Date 05/01/2023

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 in the middle of the first treatment pass during the aquablation procedure, the aquabeam handpiece failed to aspirate.During the setup, the gray clip on the aspiration tubing was mistakenly repositioned due to an user error which caused slight kinking in the tubing.As a result, the aquablation procedure was aborted due to unusual noises and the absence of water flow from the tubing during the procedure.Upon examination, it appeared that something was obstructing the handpiece as the sheath could not retract fully.It was also noted that the patient had a previous pul (prostate urethral lift) procedure, which might have caused an obstruction in the handpiece.No adverse health consequences to the patient were reported 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

The aquabeam handpiece was not returned for investigation as it was disposed of at the user facility.A review of the device history record (dhr) (b)(4) / serial number (b)(6) and aquabeam handpiece / lot number 23c00627 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.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 constitue 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: 16938990
• MDR Text Key: 315304605
• Report Number: 3012977056-2023-00076
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20220217A
• 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: 07/17/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: No
• 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