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

Model Number AB2000

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

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

Event Date 04/27/2023

Event Type  malfunction  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently inprocess.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 aquablation procedure, the treating surgeon realized that the aquabeam scope had been inserted into the wrong channel in the aquabeam handpiece.The scope was removed from the handpiece and multiple attempts to insert it into the handpiece were not successful.A second handpiece was used with the same result.A third handpiece was able to resolve the issue and the procedure was successfully completed.The reported event caused a surgical procedure delay of over 20 minutes.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

The aquabeam handpiece was not returned for investigation as it was disposed of at the user facility.A review of the device history record (dhr) ab2000-b/ serial number (b)(6) and the aquabeam handpiece / lot number 23c00389 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 current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.11.2.5 sterile: aquabeam handpiece and aquabeam scope setup retract the scope tube tip on the aquabeam handpiece to 1 inch (2.54 cm) in front of its fully proximal position.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 (2.54 cm) 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.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.The root cause of the reported event was unable to be established due to the inability to physically investigate the device.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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065
• MDR Report Key: 16950802
• MDR Text Key: 315696070
• Report Number: 3012977056-2023-00074
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20210510A
• 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: 07/05/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 06/13/2023
• Supplement Dates FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male