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 09/11/2023

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 aquablation procedural set up, the gray clip on the aspirating tube was noted to be incorrectly placed.The gray clip was moved and the aquabeam handpiece was primed with no issue.During the first treatment pass, the handpiece failed to aspirate.As a result, the aquablation procedure was aborted and converted to transurethral resection of the prostate (turp) surgery.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

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.

Manufacturer Narrative

The aquabeam handpiece was not returned for investigation as it was disposed of at the user facility.The root cause of the reported event could not be established as the handpiece was not returned for investigation.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 23c02073 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 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; 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: 17789123
• MDR Text Key: 323933686
• Report Number: 3012977056-2023-00157
• 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: 11/13/2023

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 Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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