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 3012977056-2020-00028).There were no adverse health consequences as a result of the reported event.

Manufacturer Narrative

H3.Device evaluation by manufacturer: the aquabeam robotic system motorpack was returned for investigation.Functional testing was unable to reproduce the e22 or e31 errors during a total of 6 docking cycles, 6 simulated jet alignments, and 3 simulated treatments.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." "e31 - motorpack error release foot pedal and click x.If error persists, replace handpiece." no problem was found with the returned motorpack.Functional testing was unable to reproduce the e22 or e31 errors during a total of 6 docking cycles, 6 simulated jet alignments, and 3 simulated treatments.The reported event was determined to be related to the associated aquabeam robotic system handpiece (refer to associated mfr.Report number 3012977056-2020-00028).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: 10315950
• MDR Text Key: 202700110
• Report Number: 3012977056-2020-00029
• 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: 12/17/2020
• Supplement Dates FDA Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AQUABEAM HANDPIECE, LOT NUMBER 20C00072R1