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

Model Number AB2000

Device Problems No Display/Image (1183); Output Problem (3005)

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

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently inprocess.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the procedure, as the treating physician tried to confirm contour plan for the second treatment pass by pressing the plus button on the aquabeam motorpack, the aquabeam conformal planning unit (cpu) screen turned black.Troubleshooting efforts were unable to resolve the issue with the cpu and continue with the second treatment pass; therefore, the treating physician proceeded to resect the remnant prostatic tissue.The event caused a procedural delay of over 20 minutes.The patient was reported in good condition.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam cpu was returned for investigation.Functional testing was unable to reproduce the reported event; however, the application log file review observed the cpu powered down at 11:13:42 and was never powered back on, which confirms the reported event.Additionally, the os log file review observed instances of the cpu with improper power cycles that spanned from may 2021 to october 2021, which potentially damaged and corrupted the operating system (os) of the cpu.The damaged/corrupted os can trigger the black screen described in the reported event.A review of the device history record (dhr) for serial number (b)(6) and the aquabeam cpu / lot number 20c00888 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 no other similar events reported to procept.Aquabeam robotic system user manual, um0104-00 rev.F, was reviewed and states the following: 11.2.21 aquabeam robotic system disassembly.Power off the cpu and console.Caution: use the power off button in the upper right corner of the cpu screen to shut down the cpu.Using other means to power off may lead to file system corruption or damage to the cpu.The root cause of the reported event was established to be user-related.The user manual explicitly mentions "using other means to power off may lead to file system corruption or damage to the cpu." , indicating that the user failed to properly shut down the cpu.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: 12686110
• MDR Text Key: 278126211
• Report Number: 3012977056-2021-00087
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20210127C
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male