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 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

Root cause of 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.Component code = 4755 - aquabeam console, a reusable component of the aquabeam robotic system, controls the functionality of the high-velocity waterjet delivered by the aquabeam handpiece.

Event Description

A male patient underwent aquablation therapy for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation was informed that during the aquablation treatment, the aquabeam robotic system encountered an "e03 -console error" when priming a handpiece at 100% power during setup.Despite clearing the error and attempting priming multiple times with different handpieces, the error persisted.Eventually, the treatment was successfully completed by priming at 50% power and adjusting the treatment plan accordingly.The incident resulted in a surgical delay over 20 minutes.There were no adverse health consequences to the patient due to this event.

Manufacturer Narrative

For correction, refer to section d.4.Serial #.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

N/a.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr; san jose 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr; san jose 95134
• MDR Report Key: 19068503
• MDR Text Key: 340396376
• Report Number: 3012977056-2024-00102
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20220318C
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2024

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 Catalogue Number: AB2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/18/2022
• 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