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); Audible Prompt/Feedback Problem (4020)

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

Event Date 10/06/2020

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 an "e22 - motorpack error" occurred with the aquabeam robotic system, which caused a procedural delay of over 20 minutes.The error message was cleared by replacing the aquabeam robotic system handpiece 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 robotic system handpiece was returned for investigation.Functional testing was able to reproduce the reported "e22 - motorpack error" persistently.Additional analysis observed that the sensor board was misaligned with respect to the carriage.The manufacturing process was reviewed and instructions to visually align the sensors were present.A review of the aquabeam robotic system log files confirmed the reported "e22 - motorpack error" message during the aquablation procedure.The total delay to the procedure was determined to be 20 minutes and 6 seconds, consistent with the reported delay.The procedure was observed to continue to completion normally.A review of the device history record (dhr) for serial number (b)(6) was conducted, which confirmed that there was no nonconformances generated during the manufacturing process of this system, which was unrelated to the reported event.The review indicated that the system met all required specifications upon release for distribution.No similar complaints have been reported across all lots/serial numbers for this issue.The aquabeam robotic system's user manual (intl), um0104-00, rev.F, 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." due to the manufacturing specifications providing adequate instructions to ensure the sensors are aligned and the observed sensor board misalignment upon return of the device, the root cause of the "e22 - motorpack error" reported by the field was determined to be due to manufacturing.This is the first occurrence of the failure mode of the sensor board misalignment, (complaint rate of 0.15% from (b)(6) 2020 to (b)(6) 2021).Therefore, no escalation is required or recommended at this time.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: 10796284
• MDR Text Key: 219191564
• Report Number: 3012977056-2020-00060
• 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: 01/29/2021

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: 10/23/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1