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

Model Number AB2000

Device Problems Failure to Prime (1492); Priming Problem (4040)

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

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: (b)(4).Root cause of reported event has not yet been established.Investigation by manufacturer is currently inprocess.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 procedure the treating surgeon was unable to prime with the aquabeam console.As a result, the treating physician decided to abort the aquablation procedure.There were no adverse health consequences to the patient due to the reported event.

Manufacturer Narrative

H.10 additional manufacturer narrative: h.6 adverse event problem.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.H.3 device evaluation by manufacturer: the aquabeam console was not returned for investigation as it remains functional at the customer site.The reported event was isolated to the aquabeam motorpack, which was returned for investigation.A review of the event log files observed no instances of full priming and cannot determine whether the plus (+) and minus (-) buttons were pressed on the console or motorpack.Functional testing could not reproduce the reported failure mode of the motorpack unable to prime at 100% pump power.The motorpack buttons functioned as expected and successfully completed an aquablation cycle without any issues or anomalies.The motorpack functioned as expected and thus, the root cause remains undeterminable on how the motorpack failed to prime at 100% pump power.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam motorpack / lot number 19c01044 was conducted, which confirmed that the system and associated components met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use, ifu-0101-00 rev.E, was reviewed and states the following: section 8.14 sterile: ensure the aquabeam scope is fully advanced prior to priming.Press the "prime" button on the foot pedal or console and circle priming indicators (100% and 50%) will appear on the cpu.Press the [+] button on either the console or the motorpack to prime the aquabeam handpiece at 100% power level.Continue to press the [+] button until the 100% yellow indicator turns green.Release the [+] button while pressing the prime button until the 50% yellow indicator turns green.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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494
• MDR Report Key: 15945839
• MDR Text Key: 308014967
• Report Number: 3012977056-2022-00167
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20190916T
• 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: 12/29/2022

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: 09/30/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 12/22/2022
• Supplement Dates FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male