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

Model Number AB2000

Device Problem No Display/Image (1183)

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

Event Date 05/19/2023

Event Type  malfunction  

Manufacturer Narrative

Visual testing has confirmed a poor visualization with the aquabeam scope as reported by the user, this is indicative of a fiber optic break due to repetitive use of the scope a review of the device history record (ohr) ab2000-b/ serial number (b)(6), and aquabeam scope with lot number 72003/s0025 was conducted, which confirmed that there was no non-conformance issued to this lot of the handpiece during the manufacturing process that could potentially be related to the reported event.The lot passed all final inspections and was released successfully per device specifications.The aquabeam robotic system user manual, um0101-00 rev.F, 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 the aquabeam scope is a reusable component where the service life is largely determined by wear, reprocessing methods, and any damage during use or handling.The aquabeam scope is within serviceable life as long as it remains undamaged and functional according to the inspection criteria prior to use provided to the reprocessor per ifu0204-00, aquabeam scope reprocessing instructions, intl, rev.F.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.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.

• 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: 17121484
• MDR Text Key: 317683412
• Report Number: 3012977056-2023-00091
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20200831B
• 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
• Report Date: 05/31/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2020
• 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