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

Model Number AB2000

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 01/29/2022

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: adverse event problem (b)(4) aquabeam console, a reusable component of the aquabeam robotic system, controls the functionality of the high-velocity waterjet delivered by the aquabeam handpiece.Device evaluation by manufacturer.The aquabeam console was returned for investigation.The console was observed to have an aquabeam handpiece pump cartridge loaded inside the high pressure pump assembly.Upon initial inspection, the pump cartridge could be easily removed from the console.The outer diameter of the pump cartridge measured within specification, thus ruling out the pump cartridge diameter as the cause for failure.The console was opened and the helical gear responsible for the latching function was broken, hence confirming the latching difficulty experienced during this event.The gear was in the correct orientation and was within specifications.There was no evidence of any nonconformity with the console lever or gear.A review of the device history records (dhr) for ab2000/serial number (b)(4) and associated aquabeam console, fg220102 rev d/lot number (b)(4), was performed, which confirmed that no nonconformances were generated during the manufacturing process.The review indicated that the system and associated component met all required specifications upon release for distribution.A review of similar complaints confirmed two (2) other similar events have been reported to procept.Aquabeam robotic system user manual, um0101-00 rev.F, states: table 4 aquabeam robotic system status indications confirm cartridge is fully seated into pump head and close latch (note: latch provides a tactile click upon closure).Based on the investigation, it is likely that the helical gear in the latching mechanism was unable to withstand the forces applied while trying to latch and unlatch the pump cartridge leading to this failure.However, without knowing the exact details of when, how, and who performed the setup prior to the procedure, the root cause remains undeterminable at this time.

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, difficulty was encountered latching the aquabeam handpiece to the aquabeam console.As a result, the treating physician decided to abort the aquablation procedure.There were no adverse health consequences to the patient due to the reported 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: 13596273
• MDR Text Key: 286539475
• Report Number: 3012977056-2022-00017
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D202112298
• 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
• Report Date: 02/24/2022

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: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2022
• Initial Date FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2021
• 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