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

Model Number AB2000

Device Problem Optical Distortion (3000)

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

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

The aquabeam scope has not yet been returned to the manufacturer for investigation.

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 and had to be replaced to continue the procedure through successful completion.The reported event caused a surgical procedural delay of over 20 minutes.There were no adverse health consequences with the patient because of this event.

Manufacturer Narrative

H.3 device evaluation by manufacturer: the scope was not returned for investigation.Three (3) good faith efforts were made by procept to retrieve the scope for investigation without success.A review of the device history record (dhr) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system and/or scope associated to this event.The review indicated that the system and/or scope met all required specifications upon release for distribution.A similar complaint review was performed across all other lots confirmed six (6) similar complaints.The aquabeam robotic system user manual, um0101-00 rev.F, states the following: 5.3 precautions: aquabeam scope setup: ensure the aquabeam scope and aquabeam handpiece have 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 aquabeam 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.The scope was not returned for investigation.Three (3) good faith efforts were made by procept to retrieve the scope for investigation without success.The root cause of the reported could not be determined due to the inability to 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 1494
• MDR Report Key: 11606517
• MDR Text Key: 245093856
• Report Number: 3012977056-2021-00014
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

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
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 09/24/2021
• Supplement Dates FDA Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1