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

Catalog Number AB2000

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

Root cause of the reported event has not yet been established.Investigation by manufacturer 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 (procept) became aware that during procedural setup, the aquabeam robotic system generated an "e22 - motorpack error" message.Multiple troubleshooting steps attempted to clear the error message were unsuccessful.A second aquabeam handpiece was used and the aquablation procedure began.During nozzle registration, the high-velocity waterjet was not firing and the aquabeam robotic system generated an "lp jet" message.Multiple troubleshooting steps were attempted; however, the high-velocity waterjet still wouldn't fire.A third aquabeam handpiece and second aquabeam motorpack were used to resolve the issue.The reported event caused a surgical delay of over 20 minutes.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

Three (3) good faith attempts were made to retrieve the device; however, the aquabeam handpiece was not returned for investigation.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam handpiece / lot number 23c00339 was performed, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported failure.The review indicated that the device met all design and manufacturing specifications when released for distribution.The current instructions for use ifu0101-00 rev.E , states the following: 8.30 sterile: treatment: a.To begin the aquablation treatment, step on the foot pedal and gently support the beige braided tubing extending from the back of the aquabeam handpiece.Caution (for system models other than ab2000c): failure to support the beige braided tubing may result in a system fault or insufficient cutting efficacy.A.During the aquablation treatment, use [-] indicator on the motorpack to decrease power/resection depth (if needed) and use [+] to increase back to planned power.The root cause of the reported event was unable to be established as the handpiece was not returned for investigation.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; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech drive; san jose, CA 95134 ; 6502327291
• MDR Report Key: 18387171
• MDR Text Key: 331391448
• Report Number: 3012977056-2023-00252
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20220627R
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2022
• 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