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

Model Number AB2000

Device Problems Failure to Prime (1492); Priming Problem (4040)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause of the reported event has not yet been determined.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 setup step of the aquablation procedure the aquabeam handpiece was unable to prime, which caused a 25-minute procedural delay.The aquablation procedure was successfully completed with a new aquabeam handpiece.There were no adverse health consequences with the patient due to this event.

Manufacturer Narrative

The aquabeam robotic sytem handpiece was not returned for investigation of this event.The aquabeam robotic system's log file was reviewed, which confirmed that during aquabeam robotic system handpiece priming the operator was consistently pressing the [-] button indicator on either the aquabeam robotic system console or aquabeam robotic system motorpack and the priming button was released stopping the priming.The aquabeam robotic system handpiece was replaced in order to continue the procedure.The total procedural delay time was 23 minutes and 26 seconds.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 the lot number of the aquabeam robotic system handpiece (20c00086) confirmed that there were no nonconformances generated during the manufacturing process; the lot met required specifications prior to release for distribution.A review for similar complaints was performed on serial number (b)(6), which confirmed one other similar event reported.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, rev.A.Under section 8.16 states the following: press the "prime" button on the foot pedal or console and circle priming indicators (100% and 50%) will appear on the cpu.Press the [+] button on either the console or the motorpack to prime the aquabeam handpiece at 100% power level.Continue to press the [+] button until the 100% yellow indicator turns green.Release the [+] button while pressing the prime button until the 50% yellow indicator turns green.The aquabeam robotic system handpiece was not returned for investigation of this event.A review of the log file on this event confirmed that during the aquabeam robotic system handpiece priming the operator was consistently pressing the [-] button indicator on either the aquabeam robotic system console or aquabeam robotic system motorpack and the priming button was released stopping the priming.Per the aquabeam robotic system's ifu, the operator is to press the [+] button on either the aquabeam robotic system console or the aquabeam robotic system motorpack to prime the handpiece at 100% power level.Pressing the [-] button indicator decreases the power level.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: 10261633
• MDR Text Key: 199314732
• Report Number: 3012977056-2020-00024
• 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: 10/22/2020

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: 06/10/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1