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

Model Number AB2000

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation by manufacturer has begun, but not yet completed.Adverse event problem.(b)(4).

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the procedure, with 1 minute and 30 seconds left in the second and final treatment pass, an "e03 - console error" message occurred with the aquabeam robotic system console.Multiple attempts were made to troubleshoot the error message without success; therefore, the decision was made to abort the aquablation procedure and complete the treatment with cauterization with cauterization.There were no adverse health consequences to the patient because of the reported event.

Manufacturer Narrative

H.3 device evaluation by manufacturer: the aquabeam console was returned for investigation.The reported "e03 - console error" message was able to be reproduced in addition to a "e02 - console error" message.E02 was triggered when priming at 50% and e03 was triggered priming at 100% pump power.The encoder was observed to have irregular signals using an oscilloscope, which was a sign of a misaligned encoder wheel.Contaminants observed on the encoder were tested to be pump cartridge piston oil and is funneled through the pump nest intake.However, this contaminant is a lesser contributor to the e02/e03 compared to a misaligned encoder.A review of the aquabeam robotic system's log file confirmed the e03 error message in addition to an e02 error message.A total downtime of 7 minutes 58 seconds of downtime.The procedure was halted with 1 minute and 30 seconds left on the 2nd pass.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 aquabeam console associated to this event.The review indicated that the system and/or aquabeam console met all required specifications upon release for distribution.A review of similar complaints confirmed that there are two (2) other similar events.The aquabeam robotic system user manual, um0101-00 rev.E, states: table 5 system detected errors 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 encoder misalignment was due to the incorrect spacer tool being used.A new spacer tool was implemented on 19-nov-2020 to address encoder alignment issues.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: 11181493
• MDR Text Key: 227589019
• Report Number: 3012977056-2021-00001
• 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: 05/21/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1