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

Model Number AB2000

Device Problem Positioning Problem (3009)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted over the 30-days requirement due to an "unexpected error for product code (pzp)" in esubmitter, which would not allow the submission to be saved.The issue was resolved by the esubmitter support team on 09-aug-2021.Root cause of reported event has not yet been established.Investigation by manufacturer is currently inprocess.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the procedure the aquabeam scope could not be latched into the aquabeam handpiece.The treating physician removed the aquabeam handpiece from the patient and tried reconnecting the scope into the handpiece without success.The handpiece was replaced with a new handpiece device and the procedure was able to be successfully completed.The reported event caused a procedural delay of over 20 minutes.There were no adverse health consequences to the patient due to the reported event.

Manufacturer Narrative

H.10 additional manufacturer narrative: through good faith efforts to obtain the device for investigation it was confirmed that the device is not available for investigation.A review of the device history records (dhr) for ab2000/serial number (b)(6) and aquabeam handpiece/lot number 19c01645 were performed, 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 and its associated component met all design and manufacturing specifications when released for distribution.A review of similar complaints identified two (2) other similar complaints that have been reported to procept.The aquabeam robotic system user manual, um0102-00, states the following: 4.2.Precautions: aquabeam scope setup ensure aquabeam scope is properly engaged with camera and light source.Failure to do so may result in user or patient injury.Take precautions during installation, use, and removal of light source to the aquabeam scope light source adapter and distal lens as the surfaces may heat up from light source.Ensure aquabeam scope has no sharp edges, rough surfaces, protrusions, and/or damage to the device.Failure to do so may result in user or patient injury.Inspect for particulates at the distal end of the scope where the lens is located.If particulates are found around the lens, thoroughly wipe them off using a sterile gauze wetted with sterile water or saline.Ensure aquabeam scope clamp is properly installed and the sterile field is maintained.The root cause of the reported event could not be determined, as the device was not returned for investigation.Complaint data is monitored and trended on a monthly basis as part of procept's quality management system; shall a trend arise for this failure mode, then further actions will be considered.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
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494
• MDR Report Key: 12304322
• MDR Text Key: 266005753
• Report Number: 3012977056-2021-00062
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/22/2022

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: 07/07/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male