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

Model Number AB2000

Device Problem No Flow (2991)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: 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 became aware that during the aquablation procedure there was no movement of the high-velocity waterjet on the aquabeam handpiece.Several troubleshooting steps were taken in an attempt to address the issue, including replacing the aquabeam handpiece three (3) times without success.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

H.10 additional manufacturer narrative: the investigation of the returned aquabeam handpiece confirmed that the device had been severed and the severed portion was not returned for investigation, not allowing for functional testing to confirm the reported failure mode.A review of the device history record (dhr) ab2000-b rev g / serial number (b)(6) / lot number 21c01835 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 and associated component met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 8.24 sterile: align waterjet nozzle by doing the following: a.Rotate the trus stepper cradle (if needed) to center the aquabeam handpiece hyperechoic artifact with the vertical yellow line.B.Press the foot pedal to visualize position of waterjet (retract trus probe if needed by using knobs on trus stepper).C.Waterjet needs to be visible at 3 or 9 o'clock.D.If slightly off, depress the black button on the mag block (located on the handpiece articulating arm) and rotate the aquabeam handpiece axis while stepping on foot pedal to align jets to 3 and 9 o'clock position.A root cause for the reported event could not be determined due to the condition of the returned handpiece, which did not allow functional testing to be conducted.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: 15466271
• MDR Text Key: 302174273
• Report Number: 3012977056-2022-00126
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20210510A
• 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: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

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: 08/25/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 11/09/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• 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