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

Model Number AB2000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 11/08/2021

Event Type  malfunction  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation procedure an "e22 - motorpack error" message was generated by the aquabeam robotic system.The error message was unable to be cleared after multiple troubleshooting steps were taken.The treating physician proceeded to abort the aquablation procedure and converted to a transurethral resection of the prostate (turp) surgical procedure.There were no adverse health consequences to the patient due to the reported event.

Manufacturer Narrative

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

Manufacturer Narrative

H10 additional manufacturer narrative: the aquabeam robotic system and associated component, aquabeam handpiece, were returned for investigation.A review of the log file confirmed the reported "e22 - motorpack error" error message.Functional testing could not reproduce the e22 error during the aquablation cycles and passed the criteria of a functional handpiece.The handpiece signals were captured and observed no signal anomalies.Additionally, the handpiece shell was opened, and some signs of fluid ingress were observed on the encoder wheel but was not sufficient to have contributed to triggering the reported e22 error message.A review of the device history record (dhr) for ab2000/serial number (b)(6) and aquabeam handpiece/lot number 21c00304r1 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 met all design and manufacturing specifications when released for distribution.A review of similar complaints for a 12-month period confirmed 15 similar events have been reported to procept.The aquabeam robotic system user manual, um0104-00 rev.F, was reviewed and states the following: 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.Although, the reported "e22 - motorpack error" was confirmed during a review of the log file, it was not possible to replicate the error during investigation.The root cause of the reported event was unable to be established.Complaint data is tracked and trended as part of procept quality management system; should a trend arise for this failure mode, further actions will be considered.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: 12972995
• MDR Text Key: 284988708
• Report Number: 3012977056-2021-00097
• 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: 05/06/2022

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
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 04/29/2022
• Supplement Dates FDA Received: 05/07/2022
• Was Device Evaluated by Manufacturer?: No
• 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