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

Model Number AB2000

Device Problems Mechanical Problem (1384); Visual Prompts will not Clear (2281); Mechanical Jam (2983)

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

Event Date 06/09/2023

Event Type  malfunction  

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.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during the aquablation procedure, the jet probe appeared to be jammed into the aspiration tubing, and an "e31 - motorpack error" message was generated by the aquabeam robotic system which could not be cleared despite multiple troubleshooting steps.As a result, the aquabeam handpiece was replaced with a new handpiece unit, and the procedure was successfully completed.The reported event caused a surgical procedure delay of over 20 minutes.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

The aquabeam handpiece was returned for investigation.Visual inspection of the returned handpiece was observed to have some physical damages as the shell could be seen slightly separating near the handpiece tab.Functional testing of the returned device could not confirm the reported event.The handpiece was deconstructed and viewed under magnification.No signs of damage, loose components, or any anomalies were observed which would cause an e31 error to occur.The root cause is undeterminable as it is unknown what caused the e31 error.The aquabeam robotic system's treatment logs file was reviewed, which confirmed the reported event.A review of the device history record (dhr) (b)(4) / serial number:(b)(6) and aquabeam handpiece / lot number: 23c00826 was conducted, 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 reworked to address the nonconformance.Upon re-inspection, the lot met all required specifications and was then deemed acceptable to be released for distribution per device specifications.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.Table 5 system detected errors and faults: e31 - motorpack error.Release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece.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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065 ; 6502327291
• MDR Report Key: 17167207
• MDR Text Key: 317658225
• Report Number: 3012977056-2023-00100
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20200730A
• 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: 08/28/2023

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: 06/09/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 08/06/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2020
• 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