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 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned to the manufacturer for investigation.The investigation 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 "e22 - motorpack error" and "e21 - motorpack error" messages occurred with the aquabeam robotic system.Multiple attempts were made to troubleshoot the error messages, causing a procedural delay of over 40 minutes.The error messages were cleared by replacing the aquabeam robotic system handpiece with a new unit and the procedure was successfully completed.There were no adverse consequences to patient's health because of the reported event.

Manufacturer Narrative

H3.Device evaluation by manufacturer: the aquabeam handpiece was returned for investigation.Visual inspection of the handpiece found the position indicator was at 60mm; there were small amounts of blood around the connector pins and pump cartridge.Functional testing could not replicate the reported "e22 - motorpack error" and "e21 - motorpack error" messages.Three (3) docking simulations were performed with no occurrence of "e22 - motorpack error" and "e21 - motorpack error" messages.A review of the aquabeam robotic system's log file was performed, which which confirmed the reported "e22 - motorpack error" and "e21 - motorpack error" messages.The total procedural delay was 43 minutes and 52 seconds.A review of the device history records (dhr) was conducted for aquabeam robotic system/handpiece, 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/handpiece met all design and manufacturing specifications when released for distribution.A review for similar complaints confirmed one (1) other similar event reported to procept biorobotics.A revew of the aquabeam robotic system user manual, um0102-00 rev c, states: 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." "e21 - motorpack error 1) release foot pedal and click x.2) if error persists, replace motorpack." the root cause of the reported event was unable to be determined.Functional testing of the returned handpiece could not replicate the reported "e22 - motorpack error" and "e21 - motorpack error" messages.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: 10997948
• MDR Text Key: 221268536
• Report Number: 3012977056-2020-00079
• 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: 05/25/2021

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: 12/14/2020
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/13/2020
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1