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

Model Number AB2000

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005); Audible Prompt/Feedback Problem (4020)

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

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause of the reported event has not yet been determined.Investigation 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 set-up process, while performing jet alignment, system error message "e22 - motorpack error" was displayed multiple times and troubleshot, which caused a procedural delay greater than 20-minutes.The aquabeam handpiece and aquabeam motorpack were replaced and the procedure was successfully continued to completion (refer to associated mfr.Report number 3012977056-2020-00029).There were no adverse health consequences as a result of the reported event.

Manufacturer Narrative

H3.Device evaluation by manufacturer: the aquabeam robotic system handpiece was returned for investigation.Functional testing was unable to reproduce the e22 error during 3 docking cycles and 3 simulated jet alignments during the alignment step of the procedure.Additional analysis opened the handpiece shells and dried saline deposits were observed on the z-sensor and r-sensors on the sensor board; the e22 and e31 errors in the field were determined to have been caused by fluid getting into the handpiece.Fluid was determined to have gotten into the handpiece due to damage to the high-pressure hose of the cartridge.A review of the system's log file was conducted, which confirmed the reported "e22 - motorpack error" message in addition to "e31 - motorpack error" message.The total delay was determined to be 15 minutes and 39 seconds, inconsistent with the initial reported delay of greater than 20-minutes.The procedure was observed to have proceeded to completion.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 complaints was performed on serial number (b)(6), which confirmed that there were no other similar events reported on this system.A review for similar events across all systems confirmed no other events.The aquabeam robotic system's user manual (intl), um0104-00, rev.D, states the following in table 5 system detected errors and faults: "e22 - motorpack error release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece." the root cause of the e22 and e31 error messages was determined to be fluid getting onto the sensor board due to damage to the high-pressure hose caused by the manufacturing process.The manufacturing process has been updated to perform preventive maintenance to inspect the tool for damage and the high-pressure hose for scratches or damage.This is the first occurrence of this failure mode (b)(4); therefore, no escalation is required or recommended at this time.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: 10315840
• MDR Text Key: 202700399
• Report Number: 3012977056-2020-00028
• 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: 12/21/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AQUABEAM MOTORPACK, LOT NUMBER 19C01629.