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

Model Number AB2000

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause of the reported event has not yet been determined.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 setup, the aspiration and irrigation tubes separated from the manifold of the aquabeam handpiece.The aquabeam handpiece was replaced with a new aquabeam handpiece and the procedure was continued to successful completion.There were no adverse health consequences reported with the patient due to this event.

Manufacturer Narrative

The aquabeam handpiece was returned for investigation.Visual inspection was able to confirm the reported event that the aspiration metal tubes had come detached from the aquabeam handpiece.Further inspection found that the device was manufactured correctly.The results of the investigation are consistent with too much pressure on the tip of the aquabeam handpiece, however, the root cause of the pressure remains undetermined.This is the second occurrence, with the first occurrence on (b)(6) 2019 (b)(4) therefore, no escalation is required or recommended at this time.Complaint trends are reviewed on a monthly basis.Should a trend arise for this failure mode, further actions will be considered.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: 10255819
• MDR Text Key: 199314616
• Report Number: 3012977056-2020-00020
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• 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: 07/07/2020
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1