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

Model Number AB2000

Device Problems Leak/Splash (1354); Mechanical Problem (1384); Failure to Prime (1492); Priming Problem (4040)

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

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

Device has not yet been returned to manufacturer for evaluation; root cause has not yet been established.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 (procep) became aware that during the aquablation procedure, the aquabeam handpiece was unable to prime due to a leaking pump cartridge despite multiple troubleshooting steps, including replacing the handpiece with a new handpiece unit.A third handpiece resolved the issue, and the procedure was continued through successful completion.The reported event caused a surgical procedural delay of over 20 minutes.There were no adverse health consequences to the patient due to the procedural delay.

Manufacturer Narrative

The aquabeam handpiece was returned for investigation.Visual inspection of the returned handpiece did not reveal any anomalies.During priming, the handpiece was observed to be leaking, which confirmed the reported event.Also priming could not be completed at both 50% and 100% pump power.Further analysis was unable to determine what caused the leakage.The aquabeam robotic system instructions for use, ifu0101-00 rev.F, states the following: 5.4 precautions: aquabeam handpiece setup.· ensure the aquabeam handpiece cartridge is properly engaged with the console prior to the beginning of the procedure.An incomplete engagement may result in user or patient injury, or an inability for the aquabeam robotic system to properly resect tissue.8.14 sterile: ensure the aquabeam scope is fully advanced prior to priming.Press the "prime" button on the foot pedal or console and circle priming indicators (100% and 50%) will appear on the cpu.Press the [+] button on either the console or the motorpack to prime the aquabeam handpiece at 100% power level.Continue to press the [+] button until the 100% yellow indicator turns green.Release the [+] button while pressing the prime button until the 50% yellow indicator turns green.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam handpiece / lot number 22c04014 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 could not be established during the in-house investigation.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; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494
• MDR Report Key: 16163227
• MDR Text Key: 308484012
• Report Number: 3012977056-2023-00003
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20190315L
• 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: 03/13/2023

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 Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2019
• 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