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 Unspecified Kidney or Urinary Problem (4503)

Event Date 09/27/2023

Event Type  malfunction  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Before the aquablation therapy, the patient was treated for bladder stones.During the first aquablation treatment pass, an "e22 - motorpack error" was generated by the aquabeam robotic system.The aquabeam handpiece was removed from the patient and multiple troubleshooting steps were performed to clear the error.The treating surgeon attempted to reinsert the aquabeam handpiece into the patient; however, experienced difficulty due to urethral inflammation and a suspected false passage in the urethra.Due to these circumstances and imaging difficulties due to stool present, the treating surgeon opted to abort the aquablation procedure.The suspected false passage in the urethra was not confirmed.There were no adverse consequences to the patient due to this event.

Manufacturer Narrative

Root cause of the 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.

Manufacturer Narrative

The aquabeam handpiece was not returned for investigation as it was disposed of at the user facility.The aquabeam robotic system's treatment logs file was reviewed, which confirmed the reported "e22 - motorpack error".A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 23c03114 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, um0101 rev.F, states the following: table 5: system detected errors and faults.E22 - motorpack error.Release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece.Aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 4.3.Warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: - urethral damage causing false passage or stricture.The root cause of the reported event could not be established as the handpiece was not returned for investigation.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 ; 6502327291
• MDR Report Key: 17986690
• MDR Text Key: 326290820
• Report Number: 3012977056-2023-00177
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20230320D
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• 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