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

Model Number AB2000

Device Problems Display or Visual Feedback Problem (1184); Failure to Prime (1492); Visual Prompts will not Clear (2281); Priming Problem (4040)

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

Event Date 02/22/2023

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: 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 (procept) became aware that during jet alignment an "e22 - motorpack error" message was generated by the aquabeam robotic system, which could not be cleared despite multiple troubleshooting steps.As a result, a new handpiece unit was used; however, priming was unable to be achieved resulting in the aquablation procedure being aborted and the patient being converted to transurethral resection of the prostate (turp) surgical procedure.No adverse health consequences were reported with the patient due to this event.

Manufacturer Narrative

The aquabeam handpiece was not returned for investigation as it was disposed of at the user facility.A review of the aquabeam robotic system's log file was conducted, which provided clear visualizations of the system's attempts to purge the air after the user primed the handpiece for approximately one minute.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 22c04440 was conducted, which confirmed that 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 specifications when released for distribution.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.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.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 constitue 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; 6502327291
• MDR Report Key: 16606538
• MDR Text Key: 312296908
• Report Number: 3012977056-2023-00039
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D202112219
• 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: 05/16/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2019
• 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