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

Model Number AB2000

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted over the 30-day requirement due to an "unexpected error for product code (pzp)" in esubmitter, which would not allow the submission to be saved.The issue was resolved by the esubmitter support team on (b)(6) 2021.Component code: (b)(4): aquabeam console, a reusable component of the aquabeam robotic system, controls the functionality of the high-velocity waterjet delivered by the aquabeam handpiece.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 alignment step a "e22 - motorpack error" message was generated by the aquabeam robotic system.The error message was cleared and then a "e50 - console error" message occurred.The treating physician proceeded to abort the aquablation procedure and converted to a transurethral resection of the prostate (turp) surgical procedure.There were no adverse health consequences to the patient due to the reported event.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam console was returned for investigation.The reported "e22 - motorpack error" and "e50 - console error" message were confirmed during the log file review along with an "e23 - motorpack error".Functional testing observed no established connection between the console and cpu.The console shell was opened and it was observed that the usb com port that establishes a physical connection to the cpu was disconnected.The usb was reconnected to the console and aquablation simulation treatment without triggering the e50 or other errors and anomalies.A review of the device history records (dhr) for ab2000/serial number (b)(6) and aquabeam console/lot number 19c00024 were performed, 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 and its associated component met all design and manufacturing specifications when released for distribution.A review of similar complaints identified no other similar complaints that have been reported to procept.The aquabeam robotic system user manual, um0104-00, states the following: 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.E50 - console error.Release foot pedal and click x.If error persists, turn off and turn on console and cpu.How the usb became disconnected remains undeterminable.Thus, the root cause was not established.This is the first occurrence of this issue (complaint rate 0.038% from (b)(6) 2021 to (b)(6) 2022).Should a trend arise for these failure modes, 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
• 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: 12303478
• MDR Text Key: 265999963
• Report Number: 3012977056-2021-00061
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/21/2022

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: 08/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2019
• 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