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

Model Number AB2000

Device Problems Visual Prompts will not Clear (2281); Connection Problem (2900); Incomplete or Inadequate Connection (4037)

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

Event Date 01/10/2023

Event Type  malfunction  

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 procedure, the aquabeam handpiece was unable to be engaged to the aquabeam motorpack, and an "e31 - motorpack error" message was generated by the aquabeam robotic system.The handpiece was replaced with a new handpiece unit; however, no proper connection was possible and an "e23 - motorpack error" was generated as well and could not be resolved despite multiple troubleshooting attempts being made.As a result, the aquablation procedure was aborted.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

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.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Manufacturer Narrative

H.10 additional manufacturer narrative: additional information not previously provided under in the initial report did not indicate that the aquablation procedure was converted to turp.H.3 evaluation by manufacturer: the aquabeam motorpack was not returned for investigation of the reported event.Visual inspection revealed no physical damage.However, it was observed that saline(fluid ingress) had made its way onto the socket that connects the handpiece connector board, causing a short in the system and triggering the e22 error code.The motorpack was tested with the associated handpieces used during the aquablation procedure.Upon docking the handpiece, an immediate e22 error code was triggered.Attempts were made to clear the error code, but they proved unsuccessful, as subsequent dockings also triggered the e22 error code.In addition, log files confirmed e23, e31, and e43 errors.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam motorpack / lot number 19c01083 was performed, which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system and its associated component met all design and manufacturing specifications when released for distribution.The current user manual um0104-00 rev.F, aquabeam robotic system user manual was reviewed.Section 11.2.7 sterile: motorpack draping and docking with the aquabeam handpiece contains the note to, "verify the motorpack is securely engaged to the aquabeam handpiece by attempting to pull the aquabeam handpiece off of the motorpack.The aquabeam handpiece should remain connected to the motorpack if properly engaged." dock the motorpack to the aquabeam handpiece: - verify aquabeam handpiece nozzle position (i.E.The movement of the blue led) homes to the base of the aquabeamhandpiece (fully proximal).- apply sterile tape over the connection between aquabeam handpiece and motorpack to seal it.- keep the motorpack and the aquabeam handpiece assembly with the scope clamp assembly in a secure and sterile environment.Although the in-house investigation confirmed the reported failure mode, the root cause was unable to be established.Complaint data is monitored and trended as part of procept's quality management system; shall a trend arise for this failure mode, then further actions will be considered.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Manufacturer Narrative

The aquabeam motorpack was returned for investigation of the reported event.Visual inspection revealed no physical damage.Functional investigation confirmed that fluid ingress made its way onto an electrical component, causing a short in the system and subsequently triggering the reported e22 error code.The reported event was further confirmed during functional testing when the motorpack was tested with its associated handpieces used during the aquablation procedure.In addition, log files confirmed e23, e31, and e43 errors.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam motorpack / lot number 19c01083 was performed, which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system and its associated component met all design and manufacturing specifications when released for distribution.The current user manual um0104-00 rev.F, aquabeam robotic system user manual was reviewed.Section 11.2.7 sterile: motorpack draping and docking with the aquabeam handpiece contains the note to, "verify the motorpack is securely engaged to the aquabeam handpiece by attempting to pull the aquabeam handpiece off of the motorpack.The aquabeam handpiece should remain connected to the motorpack if properly engaged." dock the motorpack to the aquabeam handpiece: verify aquabeam handpiece nozzle position (i.E.The movement of the blue led) homes to the base of the aquabeamhandpiece (fully proximal).Apply sterile tape over the connection between aquabeam handpiece and motorpack to seal it.Keep the motorpack and the aquabeam handpiece assembly with the scope clamp assembly in a secure and sterile environment.Although the in-house investigation confirmed the reported failure mode, the root cause was unable to be established.Complaint data is monitored and trended as part of procept's quality management system; shall a trend arise for this failure mode, then further actions will be considered.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: 16326507
• MDR Text Key: 309090876
• Report Number: 3012977056-2023-00017
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20190924S
• 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,Followup
• Report Date: 05/03/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 03/06/2023; 05/03/2023
• Supplement Dates FDA Received: 03/28/2023; 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2019
• 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