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

Model Number AB2000

Device Problems Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

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

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: root cause of reported event has not yet been established.Investigation by manufacturer is currently inprocess.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that prior to treatment, as the treating physician attempted to place the aquabeam handpiece and aquabeam scope into the patient, too much pressure was applied causing the handpiece to bend.The treating physician was unable to remove the scope from the handpiece.The decision was made to abort the aquablation procedure and convert to a transurethral resection of the prostate (turp) surgical procedure to treat the patient.There were no adverse health consequences to the patient due to the reported event.

Manufacturer Narrative

H.10 additional manufacturer narrative: h.3 device evaluation by manufacturer the aquabeam handpiece and associated scope were returned for investigation.Visual inspection confirmed the scope remained attached to the handpiece and dimensional analysis confirmed the bend on the stainless-steel tubing.Functional testing confirmed the scope to be immobilized due to the bent aspiration and telescoping tube on the handpiece.The bending of the stainless-steel components of the handpiece was likely due to the handling of the handpiece from the physician mentioned in the event reporting.Additional analysis observed cracking on the adhesive on the integrated manifold, which is an indicator that excessive force was applied and further confirmed that excessive force was being applied as stated in the reported event.A review of the device history records (dhr) for ab2000/serial number 21c00313 and aquabeam handpiece/lot number 20c00843, and aquabeam scope, lot number 72011, were 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 components met all design and manufacturing specifications when released for distribution.A review of similar complaints identified one (1) other similar event has been reported to procept.The aquabeam robotic system user manual, um0101-00 rev.F, states the following: 11.2.5 sterile: aquabeam handpiece and aquabeam scope setup states: -hold the distal end of the scope tube tip approximately 1 inch (2.54cm) from the fully proximal position and continue advancing the aquabeam scope forward until it is properly engaged with the aquabeam handpiece and then rotate the proximal key alignment adapter so that the dimple on the proximal key alignment adapter is facing up.-an audible click should be heard when the aquabeam scope is securely engaged with the aquabeam handpiece.Note: do not use excessive force to advance the aquabeam scope.If resistance is felt, gently rotate the aquabeam scope clockwise and counterclockwise while simultaneously applying forward pressure.The aquabeam robotic system user manual, ifu0101-00 rev.E, states the following: 5.1.Precautions: general: if excessive resistance is encountered during aquabeam scope positioning, reposition the aquabeam handpiece to minimize tenting the prostate in order to reduce the chance of damaging the aquabeam scope.The root cause was determined to be user related as excessive force was applied, causing the handpiece to bend and left the scope stuck within the handpiece.The aquabeam robotic system user manual instructs the user to reposition the handpiece if resistance is encountered.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: 12182268
• MDR Text Key: 261996345
• Report Number: 3012977056-2021-00049
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• 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: 01/19/2022

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: 07/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/16/2021
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2021
• 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