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); No Flow (2991)

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

Event Date 01/03/2023

Event Type  malfunction  

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, no movement of the high-velocity waterjet was seen on the aquabeam handpiece followed by an "e22- motorpack error" message.Several troubleshooting steps were taken in an attempt to address the issue, including replacing the aquabeam handpiece but ultimately the issue was resolved by connecting and disconnecting the aquabeam console and the procedure was continued through successful completion.The reported event caused a surgical procedural delay of over 20 minutes.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

Additional manufacturer narrative: 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.

Manufacturer Narrative

The aquabeam handpiece was returned for investigation.A review of the treatment log files confirmed the reported "e22 - motorpack error" and additional "e23 - motorpack error" errors during the alignment phase.Functional testing confirmed the priming issue but could not confirm the errors, as the handpiece completed three docking cycles and the jet alignment phase after replacing the defective inlet valve.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(4) and the aquabeam handpiece / lot number 22c03201 was performed, 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 and its associated component met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use, ifu0104-00 rev.C.States the following: 8.23.Sterile: align waterjet nozzle by doing the following: a.Toggle the trus stepper cradle (if needed) to center the aquabeam handpiece hyperechoic artifact with vertical yellow line b.Press the foot pedal to visualize position of waterjet (retract trus probe if needed by using knobs on stepper) c.Waterjet needs to be visible at 3 or 9 o'clock d.If slightly off, depress the black button on the mag block (located on the handpiece articulating arm) and rotate the aquabeam handpiece axis while stepping on foot pedal to align jets to 3 and 9 o'clock position.The priming issue and waterjet alignment issue were identified to be caused by the defective inlet valve.A complaint rate of 0.018% from 1-march-2022 to 1-march-2023.Should further issues arise, additional action will be taken to address this issue.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: 16285474
• MDR Text Key: 309076175
• Report Number: 3012977056-2023-00012
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20190307Q
• 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: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 02/02/2023
• Supplement Dates Manufacturer Received: 03/06/2023
• Supplement Dates FDA Received: 03/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2019
• 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