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

Catalog Number AB2000

Device Problem Connection Problem (2900)

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

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

Component code 4756: per the instructions for use, the aquabeam motorpack, a re-usable component of the aquabeam robotic system, provides power to the aquabeam handpiece by means of dc motors 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 procedural set-up, there was no connection between the aquabeam motorpack and the aquabeam console.As a result, the aquablation procedure was aborted and converted to transurethral resection of the prostate (turp) surgery.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

The aquabeam motorpack was returned for investigation.During functional testing, an attempt was made to jog the motors on the aquabeam motorpack and was unsuccessful.The aquabeam motorpack was disassembled and the cable subassembly was replaced with a known good one and connected to the test system.The cpu could detect the motorpack connection, turning all indicators to green.The motors responded by jogging.The root cause of the reported error is a malfunctioning cable; however, the cause of the malfunctioning cable is undeterminable.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam motorpack / lot number 21c01779 was conducted, which confirmed there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specificiations when released for distribution.The current user manual um0104-00 rev.G, aquabeam robotic system user manual, intl (ce), english was reviewed.11.2.3 non-sterile: console, motorpack, and foot pedal connection connect the motorpack cable to the front of the console: connect the motorpack plug on the front right port.Ensure the connector locks are in place and the red marks on the motorpack and the console align 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 dr; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr; san jose, CA 95134 ; 6502327291
• MDR Report Key: 17754510
• MDR Text Key: 323475482
• Report Number: 3012977056-2023-00150
• Device Sequence Number: 1
• Product Code: PZP
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

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 Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 11/30/3023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2019
• 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