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 06/30/2021

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 first treatment pass an "e22 - motorpack error" message was generated by the aquabeam robotic system.The error message was cleared, and the first pass was completed.Upon attempting a second treatment pass the "e22 - motorpack error" message reoccurred; therefore, the treating physician proceeded to abort the aquablation procedure and finished resection with a resectoscope surgical procedure.There were no adverse health consequences to the patient due to the reported event.

Manufacturer Narrative

H10: additional manufacturer narrative: the aquabeam handpiece was returned for investigation.Visual inspection observed a missing scope tube tip on the handpiece and an outward bend on the aspiration tube.Functional testing was able to reproduce the reported "e22: motorpack error" and observed backflow of fluid coming out of the top valve of the manifold.The handpiece sensor board signals were captured and observed instantaneous transitions of specific indices which are potential trigger points for e22 errors.Additional analysis observed no signs of fluid ingress, damages, or other physical anomalies on the encoder wheel and sensor board.A review of the device history records (dhr) for ab2000/serial number (b)(6) and aquabeam handpiece/lot number 21c00373 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.The aquabeam robotic system user manual, um0104-00 rev.D, states the following: "e22: motorpack error release foot pedal and click x.If error persists, reconnect handpiece to motorpack.If error continues, replace handpiece." a review of similar complaints identified 39 similar complaints that have been reported to procept.Procept is currently working on reliability project with the focus on reducing and / or eliminating, wherever possible, recurrence of e22 errors.The e22: motorpack errors observed during functional testing might be compounded by the damages observed during visual inspection adding complexity to isolating the root cause; however, how the aspiration tube and jet probe became bent is undeterminable.Thus, the root cause could not be established.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: 12222384
• MDR Text Key: 263433230
• Report Number: 3012977056-2021-00054
• 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: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 01/17/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2019
• 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