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

Model Number AB2000

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

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

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently inprocess.

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 robotic system handpiece leaked at the pump cartridge section, as a result the patient's bladder did not inflate as needed; therefore, the treating physician proceeded to abort the aquablation procedure.The procedure was converted to a transurethral resection of the prostate (turp) surgical procedure.There were no adverse consequences to patient health as a result of the reported event.

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 robotic system handpiece leaked at the manifold section, as a result the patient's bladder did not inflate as needed; therefore, the treating physician proceeded to abort the aquablation procedure.The procedure was converted to a transurethral resection of the prostate (turp) surgical procedure.There were no adverse consequences to patient health as a result of the reported event.

Manufacturer Narrative

The aquabeam robotic system handpiece was returned for investigation.Functional testing was able to be confirm the reported event of a leaking manifold.Additional analysis under magnification found that the device was manufactured correctly, however, cracks in the adhesive were observed in the irrigation tube to manifold adhesive joint, indicating stress had been applied to the bond.A review of the device history record (dhr) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system and/or handpiece.The review indicated that the system and/or handpiece met all required specifications upon release for distribution.No similar events have been reported across all other lots.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, rev.B, was reviewed and states the following: 8.16.Sterile: connect 2-way stopcock to high flow irrigation tubing and connect the luer end of the stopcock to the aquabeam handpiece.The results of the investigation are consistent with too much pressure on the tip of the handpiece, however, is unknown when the stress applied to the bond occurred and whether it was due to patient anatomy or the user, and therefore the root cause remains undeterminable.This is the first occurrence of the failure mode (complaint (b)(4) 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: 10557517
• MDR Text Key: 207711024
• Report Number: 3012977056-2020-00041
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• 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: 09/09/2020
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1