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

Catalog Number AB2000

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 10/30/2023

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 became aware that during the aquablation procedural set-up, the aquabeam robotic system generated an "e22 - motorpack error" message.A second aquabeam handpiece was used, but the error persisted.A third aquabeam handpiece was used, but the error persisted.As a result, the aquablation procedure was aborted and converted to transurethral ultrasound-guided laser-induced prostatectomy (tulip) therapy.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

The aquabeam handpiece was returned for an investigation into the reported event.No visual defects or anomalies were observed with the handpiece.Functional testing was performed on the reported handpiece, but no issues were observed.However, during priming, the handpiece pump cartridge began to leak.Upon further testing, the handpiece signals were observed to be within the nominal range.The reported event was confirmed through log files.The delrin seal was observed under magnification, revealing a large crack around the seal.However, the reason for the crack is still unknown.The root cause for the reported failure was undeterminable; however, the root cause for the leaking cartridge is attributed to the supplier.The aquabeam robotic system's treatment logs file was reviewed, which confirmed the reported event.The system triggered multiple e22 errors during the procedural setup.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 23c00935 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 aquabeam robotic system user manual, (b)(4) rev.G, states the following: table 5: system detected errors and faults.E22 - motorpack error.Release the foot pedal and click x.1) if the error persists, reconnect the handpiece to the motorpack.2) if the 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; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech drive; san jose, CA 95134
• MDR Report Key: 18166806
• MDR Text Key: 328489529
• Report Number: 3012977056-2023-00221
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/$$719C00725/16D20190719Y
• 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: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

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 Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/18/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2019
• 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