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

Model Number AB2000

Device Problems No Display/Image (1183); Output Problem (3005)

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

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned to the manufacturer for investigation.The investigation is currently in-process.

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 treating physician encountered difficulty with the transrectal ultrasound (trus) imaging, which caused a procedural delay of over 20 minutes.The aquabeam robotic system was rebooted and the procedure was successfully completed.There were no adverse health consequences to the patient as a result of the reported event.

Manufacturer Narrative

H.10 additional manufacturer narrative: the cable was not returned for investigation as it was discarded by the user facility.The aquabeam robotic system is currently in use at the user facility.A review of the aquabeam robotic system's log file was conducted, which confirmed the reported event of lost image (lost video signal) during the procedure.The total procedural delay was 47 minutes and 21 seconds.The review indicated that the procedure was successfully completed.The lot number for the cable was not provided.A review of the device history record (dhr) for serial number (b)(6) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications upon release for distribution.A review for similar events across all systems confirmed no other similar events.The aquabeam robotic system user manual, um0104-00 rev f.States the following: 5.2 precautions: aquabeam robotic system setup: ensure the aquabeam robotic system electrical connections are properly installed and secure.The reported event was confirmed during review of the log file; however, the root cause of the reported even could not be determined due to the inability to physically investigate the product.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: 10709006
• MDR Text Key: 212339562
• Report Number: 3012977056-2020-00052
• 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: 04/15/2021

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: 09/21/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1