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 03/20/2023

Event Type  malfunction  

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 jet alignment, no movement of the high-velocity waterjet was seen on the aquabeam handpiece although priming had been successfully performed prior to the jet alignment step and despite multiple troubleshooting steps, which included replacing the handpiece.As a result, the aquablation procedure was aborted, and the patient underwent a transurethral resection of the prostate (turp).There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

The aquabeam handpiece was returned for investigation of the reported event.Visual inspection of the returned handpiece did not reveal any anomalies.Functional testing of the returned handpiece could not replicate the reported issue.The handpiece was able to successfully prime at 50% and 100% pump power.During the jet alignment phase, the handpiece was able to jet in both directions and as intended.Root cause is undeterminable as reported failure mode could not be confirmed.A review of the device history record (dhr) ab2000-b/ serial number (b)(6), and aquabeam handpiece with lot number 22c03308 was conducted, which confirmed that there were two (2) non-conformance issued to this lot of the handpiece during the manufacturing process that could potentially be related to the reported event.The lot passed all final inspections and was released successfully per device specifications.The current instruction for use ifu0101-00 rev.E, aquabeam robotic system ifu, us, english was reviewed.8.23.Sterile: align waterjet nozzle by doing the following: a.Toggle the trus stepper cradle (if needed) to center the aquabeam handpiece hyperechoic artifact with vertical yellow line b.Press the foot pedal to visualize position of waterjet (retract trus probe if needed by using knobs on 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.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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island dr; suite 101; redwood city CA 94065
• Manufacturer Contact: esquivel ; 900 island drive; suite 101; redwood city, CA 94065 ; 6502327291
• MDR Report Key: 16781950
• MDR Text Key: 314013403
• Report Number: 3012977056-2023-00053
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20200928J
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

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: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2020
• 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