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

Model Number AB2000

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

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

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently in-process.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the procedure a "e22 - motorpack error" occurred with the aquabeam robotic system handpiece.The e22 error message could not be cleared; therefore, the decision was made to abort the aquablation procedure and convert to a holmium laser enucleation (holep) surgical procedure.There were no adverse health consequences to the patient as a result of this event.

Manufacturer Narrative

H3: device evaluation by manufacturer: the aquabeam handpiece was returned for investigation.The log file review and functional testing was able to confirm the reported event and failure mode.Additional analysis observed fluid ingress as salt deposits on the encoder wheel and sensor board were evident.The root cause was discovered when tiny droplets were forming on the high-pressure hose crimp priming the handpiece at 100% pump power.The handpiece may have been positioned on a downward angled during priming and pre-setup that would allow the water droplets to run onto the sensor board and encoder wheel.Leak test was performed on the returned handpiece and determined the test to be inconclusive.However, the root cause is determined to be the supplier as the leak from the high-pressure on the crimp is the likeliest source of fluid reaching the sensor board pcb.A review of the device history record (dhr) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system and/or handpiece associated to this event.The review indicated that the system and/or handpiece met all required specifications upon release for distribution.No similar events have been reported across all other lots.The aquabeam robotic system user manual, um0104-00 rev.F, states the following under table 5 system detected errors and faults: "e22: motorpack error: release foot pedal and click x.If error persists, reconnect handpiece to motorpack.If error continues, replace handpiece." "e50: console error: release foot pedal and click x.; if error persists, turn off and turn on console and cpu." the root cause is determined to be the supplier as the leak from the high-pressure on the crimp is the likeliest source of fluid reaching the sensor board pcb.This was the first occurrence of this specific failure mode (complaint rate of (b)(4) from (b)(6) 2020 to (b)(6) 2021) therefore, no escalation is required or recommended at this time.Complaint trends are reviewed on a monthly basis.Should a trend arise for this failure mode, further actions will be considered.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
• MDR Report Key: 10693865
• MDR Text Key: 211954328
• Report Number: 3012977056-2020-00047
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2021

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: 09/24/2020
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1