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

Model Number AB2000

Device Problems Failure to Prime (1492); Priming Problem (4040)

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

Event Date 01/25/2022

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 treating surgeon was unable to prime with the aquabeam foot pedal.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.

Manufacturer Narrative

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

Manufacturer Narrative

H10 additional manufacturer narrative: the aquabeam foot pedal was returned for investigation.Upon functional testing the "prime" button was depressed on the foot pedal, and a functional handpiece was able to prime at 50% and 100% pump power without issues.A full aquablation session was performed successfully by depressing the foot pedal.Instances of random water jetting or other anomalies were not observed.The foot pedal was then deconstructed and viewed under magnification.No signals of fluid ingress, damage, or anomalies were observed that may have caused the reported event.A review of the device history record (dhr) for ab2000/serial number (b)(6) and aquabeam foot pedal/lot number 19c00342 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 met all design and manufacturing specifications when released for distribution.A review of similar complaints for a 12-month period confirmed no similar events have been reported to procept.The aquabeam robotic system user manual, um0104-00 rev.F, was reviewed and states the following: 7.4 aquabeam foot pedal: the aquabeam foot pedal (figure 11), a re-usable component of the aquabeam robotic system, contains three foot-activated motion buttons.It is connected to the console with a flexible cable.The aquablate pedal is the large center button which must be depressed to enable the aquablation treatment.Depressing the aquablate pedal only activates the high-velocity waterjet during treat mode.The aquablate pedal is also used in aligning the waterjet during the alignment step at lower power.The two smaller buttons at top left and top right provide controls for priming and aspirating.The aquabeam robotic system instructions for use, ifu0104-00 rev.B, states: 8.14.Sterile: ensure the aquabeam scope is fully advanced prior to priming.Press the "prime" button on the foot pedal or console and circle priming indicators (100% and 50%) will appear on the cpu.Press the [+] button on either the console or the motorpack to prime the aquabeam handpiece at 100% power level.Continue to press the [+] button until the 100% yellow indicator turns green.Release the [+] button while pressing the prime button until the 50% yellow indicator turns green.The root cause was unable to be established.The in-house investigation was unable to reproduce the reported failure mode; the returned device 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: 13594855
• MDR Text Key: 288190893
• Report Number: 3012977056-2022-00013
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20190328W
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/06/2022

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: 01/25/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 05/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2019
• 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