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

Catalog Number AB2000

Device Problems Visual Prompts will not Clear (2281); Connection Problem (2900)

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

Event Date 11/30/2023

Event Type  malfunction  

Manufacturer Narrative

Component code 4756: per the instructions for use, the aquabeam motorpack, a re-usable component of the aquabeam robotic system, provides power to the aquabeam handpiece by means of dc motors.Root cause of reported event has not yet been established.Investigation by manufacturer 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 aquablation procedure, the connection between the aquabeam motorpack and the aquabeam handpiece was unsuccessful.Despite multiple troubleshooting attempts, the issue persisted.A second aquabeam handpiece was used, but the problem persisted.When a second aquabeam motorpack was used, the connection issue was resolved.However, the aquabeam robotic system generated an "e22 - motorpack error" and "e50 - console error." multiple troubleshooting attempts were made without success.Subsequently, a third aquabeam handpiece was used, but the aquabeam robotic system generated an "e22 - motorpack error." however, the treating surgeon was able to close out the error, and the aquablation procedure was completed successfully.The reported event caused a surgical delay of over 20 minutes.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

The aquabeam handpiece was not returned for investigation of the reported event.During functional testing, the aquabeam handpiece functioned as intended.A review of the treatment log files revealed that the aquabeam robotic system generated multiple e22 errors as well as an e23 error.No e50 error was observied.The root cause could not be determined as the aquabeam handpiece functioned as intended.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam handpiece / lot number 23c04638 was performed, which confirmed that there was one (1) non-conformance issued to this lot during the manufacturing process that could potentially be related to the reported event.The affected units within the lot were segregated and reworked to address the non-conformances.The handpiece passed final inspection prior to release for distribution.The current user manual, um0101-00 rev.F aquabeam robotic system user manual, was reviewed and states the following: 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.E50 - console error: release foot pedal and click x.If error persists, turn off and turn on console and cpu.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; 150 baytech dr; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr; san jose, CA 95134 ; 6502327291
• MDR Report Key: 18384868
• MDR Text Key: 331482900
• Report Number: 3012977056-2023-00251
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20221222I
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male