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 Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause of the reported event has not yet been determined.Investigation is currently in-process.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 procedure, while performing jet alignment, system error messages "e22 - motorpack error" and "31 - motorpack error" were displayed multiple times and troubleshot with no success; therefore, the decision was made to abort the procedure.The patient was rescheduled for aquablation procedure the following day, which was completed successfully.There were no adverse health consequences as a result of the reported event.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam handpiece was returned for investigation.During visual inspection, the aquabeam handpiece release button was not flushed with the upper handpiece shell.During functional testing, the aquabeam handpiece generated the "e22 - motorpack error" and "e31 - motorpack error" error messages.Further analysis confirmed that no power was being provided to the z-position led as it was being homed when attached to the associated aquabeam motorpack.The handpiece shell was opened and fluid ingress was observed on the z-stop sensor.A review of the system's log file was conducted, which confirmed the reported "e22 - motorpack error" message in addition to "e23 - motorpack error" message occurred eight (8) times during the aquablation procedure.No "e31 - motorpack error" message was confirmed during the review.The total procedural delay was determined to be 66 minutes and 57 seconds prior to the event being aborted.A review of the device history record (dhr) was conducted, which confirmed that there were no nonconformances related to the reported event generated during the manufacturing process of this aquabeam robotic system and/or the aquabeam handpiece.The review indicated that the system and/or handpiece met all required specifications upon release for distribution.No other similar events have been reported across all lots.The aquabeam robotic system's user manual (intl), um0104-00, rev.D, states the following in table 5 system detected errors and faults: "e22 - motorpack error: release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece." "e23 - motorpack error: release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece." "e31 - motorpack error: release foot pedal and click x.If error persists, replace handpiece." the root cause of the reported event was determined to be related to design of the device as fluid leaked into the pcb damaging the z-stop sensor, preventing power from being supplied to the light bar.This is the 1st occurrence of fluid ingress damaging the z-stop sensor and triggering an e22 error message.No corrective action is recommended at this time (complaint rate of 0.1% from 20jul2020 to 01feb2021).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: 10399772
• MDR Text Key: 202699487
• Report Number: 3012977056-2020-00034
• 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: 02/17/2021

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: 08/03/2020
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 02/17/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1