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

Model Number AB2000

Device Problems Connection Problem (2900); Incomplete or Inadequate Connection (4037)

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

Event Date 02/22/2022

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 procedure the aquabeam motorpack stopped operating after the patient had undergone a first treatment pass.It was observed that the motorpack cable began to fray at the cable strain relief.As a result, the procedure was converted to transurethral resection of the prostate (turp) surgery.There were no adverse health consequences to the patient due to the reported event.

Manufacturer Narrative

Adverse event problem: per the instructions for use, the aquabeam motorpack, a re-usable component of the aquabeam robotic system, provides power to the aquabeam handpiece by means of dc motors.Root cause of reported event has not yet been established.Investigation by manufacturer is currently inprocess.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam motorpack was returned for investigation of this event.The motorpack cable fraying at the strain relief was confirmed through visual inspection.A review of the device history record (dhr) ab2000-b/serial number (b)(6) and associated aquabeam motorpack fg220402/ lot number 20c00699 was conducted, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.The aquabeam robotic system user manual, um0101 rev.F, states the following: 11.2.3 non-sterile: console, motorpack, and foot pedal connection connect the motorpack cable to the front of the console: connect the motorpack plug on the front right port.Ensure the connector locks in place and the red marks on the motorpack and the console align.11.2.7 sterile: motorpack draping and docking with the aquabeam handpiece dock the motorpack to the aquabeamhandpiece: verify aquabeam handpiece nozzle position (i.E.The movement of the blue led) homes to the base of the aquabeam handpiece (fully proximal).Apply sterile tape over the connection between aquabeam handpiece and motorpack to seal it.Keep the motorpack and the aquabeam handpiece assembly with the scope clamp assembly in a secure and sterile environment.A similar complaint review for a 12-month perioud was conducted, which confirmed three (3) other similar events have been reported to procept.It is likely that the damage occurred during its repeated use, however cause cannot be determined.A procept reliability team is looking into improving the design of the strain relief in order to make the cable more robust to damage.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: 13883409
• MDR Text Key: 289192645
• Report Number: 3012977056-2022-00026
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20201209J
• 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: 07/22/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 07/15/2022
• Supplement Dates FDA Received: 07/22/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male