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 11/11/2021

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.

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.The aquabeam handpiece was replaced with a new handpiece unit and the aquablation procedure was continued through successful completion.The reported event caused a surgical procedural delay of over 20 minutes.There were no adverse health consequences with the patient because of this event.

Manufacturer Narrative

H.10 additional manufacturer narrative: h.3 device evaluation by manufacturer the aquabeam handpiece was returned for investigation.Functional testing confirmed that the aquabeam handpiece was able prime at 50% and 100% power; however, some jetting ocurred during priming, which is not expected.After fully priming the handpiece, an aquablation cycle simulation was performed; the jetting behavior was deemed to be abnormal.Water was seen leaking from the tip of the scope while jetting occurred.The jetting also stopped midway in the aquablation cycle.The inlet valve was removed from the piston body inside the jump cartridge to be observed under magnification.The inlet valve was observed to have no anomalies.A review of the device history records (dhr) for ab2000/serial number (b)(6) and aquabeam handpiece/lot number 21c00490r1 were 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 components met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use, ifu0104-00 rev.B, was reviewed and states the following: 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.The reported event was able to be confirmed during the investigation; however, the root cause was unable to be established, as no anomalies were observed with the inlet valve.

• 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: 12981059
• MDR Text Key: 284828180
• Report Number: 3012977056-2021-00101
• Device Sequence Number: 1
• Product Code: PZP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/21/2022

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
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 01/12/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2019
• 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