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

Model Number AB2000

Device Problem No Flow (2991)

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

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently inprocess.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 became aware that during the aquablation procedure there was no movement of the high-velocity waterjet on the aquabeam handpiece.Several troubleshooting steps were performed; however, the issue could not be resolved.The aquabeam handpiece was replaced and the aquablation procedure was continued through successful completion.The reported event caused a surgical procedural delay of over 20 minutes.There were no adverse health consequences with the patient because of this event.

Manufacturer Narrative

H10 additional manufacturer narrative: the aquabeam handpiece was returned for investigation.Functional investigation replicated the reported failure mode, as the handpiece failed to prime at 50% and 100% pump power.After confirming the reported failure mode during alignment a flowrate test was conducted and the handpiece failed to jet at pump levels 1-3 (5-15% pump power).The flowrates failed product specifications, but passed at pump power >6 (>30% pump power).The flowrate test confirmed the reported event.Additional analysis observed a warped and wavy inlet valve and flashing on the circumferential edges of the valve.These are due to the poor quality checks in the supplier injection molding of the inlet valves.The inlet valve was replaced with a known good valve and was able to jet at the lower pump levels and the flowrates measured were within specification as specified aquabeam handpiece product specifications.A review of the device history record (dhr) for serial number (b)(6) and the lot number 20c00674 for the aquabeam handpiece were 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 the aquabeam handpiece articulating armmet all design and manufacturing specifications when released for distribution.Procept has identified a trend on waterjet alignment failures and a corrective action and preventive action investigation is currently underway.The aquabeam robotic system instructions for use, ifu0101-00 rev.E, was reviewed and states the following: 8.23.Sterile: align waterjet nozzle by doing the following: a.Toggle the trus stepper cradle (if needed) to center the aquabeam handpiece hyperechoic artifact with vertical yellow line b.Press the foot pedal to visualize position of waterjet (retract trus probe if needed by using knobs on stepper) c.Waterjet needs to be visible at 3 or 9 o'clock d.If slightly off, depress the black button on the mag block (located on the handpiece articulating arm) and rotate the aquabeam handpiece axis while stepping on foot pedal to align jets to 3 and 9 o'clock position.The root cause of the reported event was determined to be poor quality checks during the manufacturing process of the inlet valve by the supplier.A corrective action and preventive action has been initiated by procept to address this issue.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: 11845627
• MDR Text Key: 260129099
• Report Number: 3012977056-2021-00032
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• 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: 11/21/2021

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
• Date Returned to Manufacturer: 05/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 11/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male