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

Model Number AB2000

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: the device evaluation has not yet began.The investigation is currently in-process.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the procedure as the treating physician turned the aquabeam robotic system scope forward, towards the bladder neck, the scope bent and broke inside the aquabeam robotic system handpiece.The reported event caused a procedural delay of over 20 minutes.The aquabeam robotic system scope and aquabeam robotic system handpiece were replaced with new units, and the procedure was successfully completed.There were no adverse consequences to patient's health because of the reported event.

Manufacturer Narrative

H.3 device evaluation by manufacturer: the aquabeam scope was returned for investigation.The reported event was able to be reproduced during visual inspection.The semi-flexible hypotube broke into two pieces severing the light fibers and the optic fiber.The scope was broken in two along with cracks in the manifold glue from a compressive load due to tenting the prostate during the procedure.A review of the device history record (dhr) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system and/or aquabeam scope associated to this event.The review indicated that the system and/or aquabeam scope met all required specifications upon release for distribution.This is the thirteenth occurrence of this failure mode (complaint rate of 0.06% from 27nov2020 to 12may2021) and the ifu and um address this issue; therefore, no escalation is required or recommended at this time.Complaint trends are monitored and reviewed on a monthly basis.Should a trend arise for this failure mode, further actions will be considered.The aquabeam robotic system's user manual, um0101-00 rev.E aquabeam robotic system user manual states: 11.2.5 sterile: aquabeam handpiece and aquabeam scope setup · verify the aquabeam scope visualization via the camera source port.Note: obtain a new aquabeam scope if proper visualization cannot be verified · while supporting the aquabeam handpiece, gently grip the middle of the semi-rigid section of the aquabeam scope and partially insert through the clear rubber seal on the bottom of the aquabeam handpiece.· 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.· confirm the aquabeam scope is fully engaged by advancing and retracting the scope proximal key and observing the scope tube tip moving in concert with the aquabeam scope.· with the proximal key fully retracted, align the scope carriage over the proximal key adapter.Attach to the aquabeam handpiece by pushing the scope carriage forward to engage with the carriage track.· using the knobs on the carriage, advance the aquabeam scope forwards (distal) and backwards (proximal) to ensure that the aquabeam scope is fully engaged with the aquabeam handpiece.The scope tube tip should move forwards and backwards in concert with the movement of the aquabeam scope.The aquabeam robotic system's instructions for use, ifu0104-00 rev.B, states: 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 of the reported event was determined to be due to tenting of the prostate during the procedure.Mishandling of the scope during setup and positioning can increase the chances of failures.The aquabeam robotic system's instructions for use and user manual contain adequate information regarding this issue.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
• MDR Report Key: 11041965
• MDR Text Key: 223764037
• Report Number: 3012977056-2020-00083
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

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: 12/10/2020
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1