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

Model Number AB2000

Device Problems Leak/Splash (1354); Mechanical Problem (1384); Infusion or Flow Problem (2964); No Flow (2991)

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

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

The aquabeam handpiece was not returned for investigation as it was discarded at the user facility.The investigation of this event consisted of the information received plus a review of the instructions for use and device history record.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.5.4 precautions: aquabeam handpiece setup: ensure the aquabeam handpiece cartridge is properly engaged with the console prior to the beginning of the procedure.An incomplete engagement may result in user or patient injury, or an inability for the aquabeam robotic system to properly resect tissue.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and associated aquabeam handpiece/lot number 23c00219 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 root cause of the reported event could not be determined due to the inability to investigate the device.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 (procept) became aware that during the aquablation procedure, saline began leaking from the handpiece pump cartridge, which would not allow sufficient pressure into the waterjet despite multiple troubleshooting steps.As a result, the handpiece was replaced with a new handpiece unit, and the aquablation procedure was successfully completed.The reported event caused a surgical procedure delay of over 20 minutes.There were no adverse health consequences to the patient due to this 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 drive; suite 101; redwood city CA 94065
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065 ; 6502327291
• MDR Report Key: 16792504
• MDR Text Key: 313807785
• Report Number: 3012977056-2023-00056
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20220624G
• 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: Other
• Type of Report: Initial
• Report Date: 04/21/2023

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?: No
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male