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

Model Number AB2000

Device Problem Poor Quality Image (1408)

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

Event Date 04/24/2023

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 aquabeam scope was unable to provide a clear visualization although troubleshooting steps were taken in efforts to address the issue.As a result, the surgeon decided to abort the aquablation procedure and converted to transurethral resection of the prostate (turp) surgery.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

The aquabeam scope was returned for investigation.Visual inspection of the returned scope did not reveal any physical damages or anomalies.Functional testing of the returned device confirmed the reported event.Debris particulates on the outer and inner lumen were observed before and after cleaning which is indicative of fluid ingress.A review of the device history record (dhr) ab2000-b/serial number (b)(6) and aquabeam scope/lot number 72106/s0060 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 aquabeam robotic system user manual, um0101 rev.F, states the following: 11.2.5 sterile: aquabeam handpiece and aquabeam scope setup.Verify the aquabeam scope visualization by viewing the image through the camera source port (the eyepiece).If any defect in the image is observed, check the cleanliness of the optical surfaces (distal and proximal lenses).The lens should appear smooth and shiny.Poor cleanliness of exterior surfaces can cause a foggy or cloudy image.Note: obtain a new aquabeam scope if proper visualization cannot be verified.The root cause of reported event was determined to be design-related.The issue has been addressed as part of procept's quality management system.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
• MDR Report Key: 16950706
• MDR Text Key: 315484811
• Report Number: 3012977056-2023-00073
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20211014C
• 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: 06/13/2023

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 Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• 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