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

Model Number AB2000

Device Problems Mechanical Problem (1384); Failure to Align (2522)

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

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently in-process.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the procedure difficulty was encountered docking the aquabeam robotic system handpiece to the aquabeam robotic system motorpack, which could not be resolved after several troubleshooting attempts; therefore, the decision was made to abort the aquablation procedure.There were no adverse health consequences to the patient as a result of this event.

Manufacturer Narrative

H.3 device evaluation by manufacturer: the motorpack was returned for investigation.There was no evidence of water ingress on the motorpack.Visual inspection of the motorpack displayed evidence of impact damage from handpiece connector boards crashing onto the motorpack connector.Functional testing confirmed the complaint handpieces not staying securely connected to the motorpack.Misalignment of the motorpack connector adds to the tolerance stack-up issue between the handpiece and the motorpack.A review of the aquabeam robotic system's log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review indicated that the system functioned as designed.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 handpiece associated to this event.The review indicated that the system and/or handpiece met all required specifications upon release for distribution.A review for similar complaints confirmed two other similar events across all lots.The aquabeam robotic system user manual, (b)(4) rev.F, states the following: 11.2.7 sterile: motorpack draping and docking with the aquabeam handpiece ensure the high-pressure tubing is centered and seated in the lower box.Dock the motorpack to the aquabeam handpiece: 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.Handpiece assembly with the scope clamp assembly in a secure and sterile environment.Verify the motorpack is securely engaged to the aquabeam handpiece by attempting to pull the aquabeam handpiece off of the motorpack.The aquabeam handpiece should remain connected to the motorpack if properly engaged.The root cause was determined to be due to the motorpack connector placement fixture used in manufacturing not reliably confining the shell so that the connector placement was able to be misaligned.A new fixture new was released to address this issue.This is the third occurrence of this failure mode, with a complaint rate of (b)(4) from (b)(6) 2020 to (b)(6) 2021.No further action is recommended at this time.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Manufacturer Narrative

H.11 corrected data: for corrected data, please refer to details of device evaluation under h.10.H.3 device evaluation by manufacturer: the motorpack was returned for investigation.The reported event was confirmed during in-house investigation.As part of functional testing, the returned motorpack was connected to an aquabeam console and it was unresponsive.The console to motorpack cable assembly was replaced with a new cable but the motorpack remained unresponsive.Our investigation confirmed the reported event.As part of functional testing, the returned motorpack was connected to an aquabeam console and it was unresponsive.The console to motorpack cable assembly was replaced with a new cable but the motorpack remained unresponsive.A review of the aquabeam robotic system's log file was reviewed, which confirmed the reported event.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 returned motorpack associated to this event.The review indicated that the system and/or motorpack met all required specifications upon release for distribution.A review for similar complaints was conducted, which confirmed no other similar events have been reported to procept.The aquabeam robotic system user manual, um0104-00 rev.F, states the following: 11.2.7 sterile: motorpack draping and docking with the aquabeam handpiece -ensure the high-pressure tubing is centered and seated in the lower box.Dock the motorpack to the aquabeam handpiece: - 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.Handpiece assembly with the scope clamp assembly in a secure and sterile environment.Note: verify the motorpack is securely engaged to the aquabeam handpiece by attempting to pull the aquabeam handpiece off of the motorpack.The aquabeam handpiece should remain connected to the motorpack if properly engaged.The root cause of the reported event could not be established.Based on the investigation, it was determined that the motorpack printed circuit board (pcb) was damaged; however, procept was unable to determine how the motorpack pcb became damaged.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: 10767658
• MDR Text Key: 214174890
• Report Number: 3012977056-2020-00059
• 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,Followup
• Report Date: 07/01/2021

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: 10/23/2020
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 11/01/2020
• Supplement Dates Manufacturer Received: 05/14/2021; 06/14/2021
• Supplement Dates FDA Received: 05/18/2021; 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1