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

Model Number AB2000

Device Problem Mechanical Problem (1384)

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

Event Date 11/10/2020

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 the aquabeam handpiece aspiration port would not aspirate.Multiple attempts were made to troubleshoot the issue without success, which caused a procedure delay of approximately 45 minutes.A new aquabeam handpiece was used to resolve the issue and the procedure was continued through successful completion.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 with the aspiration tube.The reported failure was confirmed during functional testing of the handpiece due to a complete blockage in the aspiration tube caused by excess adhesive flowing into the aspiration tube via a gap between the outer diameter and the manifold aspiration hub inner diameter.A review of the device history record (dhr) for the aquabeam handpiece and aquabeam robotic system, 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 devices met all design and manufacturing specifications when released for distribution.A review for similar complaints confirmed that there are two (2) other similar events that have been reported to procept biorobotics.The aquabeam robotic system's user manual, um0104-00 rev.F, was reviewed and states the following: 4.3 warnings: procedure -active fluid evacuation/aspiration from bladder is operational during the aquablation procedure but be attentive for any occluding tissue in the aspiration tubing during the procedure.-the aspiration tubing should not be bent, kinked, or twisted at any point during the aquablation procedure.Bending, kinking, or twisting the aspiration tubing may result in inefficient fluid aspiration.The root cause of the reported event is due to a gap between the manifold and the aspiration tube which outer diameter is too large, allowing the adhesive to easily wick into the aspiration tube.A change in the manufacturing process to address this event was implemented on 30-oct-2020; however, the subject aquabeam handpiece was manufactured prior to this implementation.No further corrective actions were required because the risk of excess adhesive was determined to be low and the aquabeam robotic system's ifu includes a warning regarding occluded aspiration tubing.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: 10953997
• MDR Text Key: 220232781
• Report Number: 3012977056-2020-00071
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

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: 11/13/2020
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/05/2020
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1