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

Catalog Number AB2000

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

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

Event Date 07/01/2023

Event Type  malfunction  

Event Description

A male patient with symptomatic benign prostatic hyperplasia (bph) received an aquablation procedure.Procept biorobotics corporation (procept) became aware that during the aquablation procedure, following the insertion of the aquabeam handpiece into the patient, the aquabeam scope encountered resistance and was unable to be advanced further.As a result, the aquabeam handpiece was removed from the patient and the aquablation procedure was aborted and converted to holmium laser prostate (holep) surgery.There were no adverse health consequences to the patient due to this event.

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.

Manufacturer Narrative

The aquabeam handpiece was returned for investigation; however, the scope carriage was not returned.Visual inspection revealed no physical damages or anomalies.Functional testing of the returned device could not confirm the reported event.The root cause is undeterminable as it is unknown how the reported event occurred a review of the device history record (dhr) (b)(4)/serial number (b)(6) and aquabeam handpiece / lot number 23c00935 was conducted, which confirmed that there was one (1) non-conformance issued to this lot during the manufacturing process that could potentially be related to the reported event.The affected units within the lot were reworked to address the nonconformance.Upon re-inspection, the lot met all required specifications and was then deemed acceptable to be released for distribution per device specifications.The current user manual um0104-00 rev.G, aquabeam robotic system user manual, intl (ce), english was reviewed.11.2.5 sterile: aquabeam handpiece and aquabeam scope setup states: 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.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.Advance the aquabeam scope forward to its fully distal position.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.Submission of this report does not constitue 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 ; 6502327291
• MDR Report Key: 17493463
• MDR Text Key: 320784152
• Report Number: 3012977056-2023-00124
• Device Sequence Number: 1
• Product Code: PZP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/13/2023

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 Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• 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