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

Model Number HP2000

Device Problem Connection Problem (2900)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation difficulty was encountered engaging the aquabeam handpiece pump cartridge to the aquabeam console.Several troubleshooting steps were performed without resolving the issue.The aquabeam handpiece was replaced with a new handpiece unit and the aquablation procedure was able to be successfully completed.The reported event caused a procedural delay of over 20 minutes.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently in-process.

Manufacturer Narrative

H10: additional manufacturer narrative: the aquabeam handpiece was returned for investigation.The handpiece pump cartridge was inserted into an aquabeam console latch and it was able to latch without any issues.The handpiece was primed successfully and one (1) aquablation cycle was run.The cycle was completed without any issues.A review of the device history record (dhr) for serial number (b)(6) and the aquabeam handpiece / lot number 21c01550 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.A review of similar complaints confirmed one (1) other other similar event reported to procept.Aquabeam robotic system user manual, um0101-00 rev.E, was reviewed and states the following: 8.9 non-sterile: insert the high-pressure pump cartridge into the console cartridge interface and turn the lever on console clockwise to secure the cartridge.A successful engagement will be confirmed by an audible and tactile click.Caution: ensure cartridge is properly engaged prior to beginning of the procedure.An incomplete engagement will result in delay in procedure.Note: if unable to engage the cartridge in the console, remove cartridge and ensure that the input line (where attached to the main assembly) is pulled approximately ½ inch (1.27cm) from the cylinder the root cause of the reported event was unable to be established.The in-house investigation was unable to reproduce the reported failure mode; the returned functioned as intended.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: 13049199
• MDR Text Key: 283632306
• Report Number: 3012977056-2021-00105
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614HP20001
• UDI-Public: +B614HP20001/$$720C00883/16D20201209I
• 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: 03/29/2022

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: HP2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2020
• 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