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

Model Number AB2000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: (b)(4).Root cause of reported event has not yet been established.Investigation by manufacturer is currently in-process.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 an "e03 - console error" message was generated by the aquabeam robotic system.The error message was unable to be cleared after multiple troubleshooting steps were performed; only one (1) treatment pass was able to be completed.The treating physician resected the remaining prostatic tissue with a loop.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam console was returned for investigation.Functional testing was able to reproduce the reported "e03 - console error" upon priming at 25% and 50% and an "e02 - console error" at 100% pump power.The e02/e03 erros prevented the system from initializing an aquablation simulation cycle.Additional analysis observed oil droplets on the encoder lens emitter and was identified to be the main cause of the e02/e03 issues.A review of the device history record (dhr) for serial number (b)(6) and the aquabeam console / lot number (b)(6) was performed, which confirmed that there were no nonconformances, 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 confirmed five (5) other similar events reported to procept.Aquabeam robotic system user manual, um0101-00 rev.E, was reviewed and states the following: table 5: system detected error and faults.E02 - console error.Release foot pedal and click x.If error persists, turn off and turn on console.E03 - console error.Release foot pedal and click x.If error persists, turn off and turn on console.The root cause of the encodercontamination have been determined to be due manufacturing related issues by a third party supplier.A corrective action and preventive action has been initiated by procept to determine appropriate actions.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: 12981017
• MDR Text Key: 285339788
• Report Number: 3012977056-2021-00102
• 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: 03/28/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 03/29/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male