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

Model Number AB2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/07/2022

Event Type  Injury  

Manufacturer Narrative

Adverse event problem: health effect clinical code: 4581 - external sphincter injury.Additional manufacturer narrative: this adverse event is being reported late to the regulatory agency due to a delay in reporting the event to the proper organization that manages adverse event reporting within procept.Additional information obtained through a company representative confirmed that the aquablation procedure was performed on (b)(6) 2022; however, the representative was made aware of the potential adverse event on (b)(6) 2022 through a third party.The company representative did not report the event until 25-jan-2023 through the complaint notification process as the information was interpreted as insufficient until more details were gathered when a follow-up was made with the treating surgeon.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.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procep) became aware that ten (10) weeks post aquablation procedure the patient is experiencing incontinence (per manufacturer instructions for use, incontinence or overactive bladder is a potential risk of the aquablation procedure).A cystogram procedure was performed on the patient, which revealed that the external sphincter had been injured during the aquablation procedure.As a result, the patient started pelvic floor physical therapy.No malfunction of the aquabeam robotic system was reported during this event.On (b)(6) 2023, procept confirmed that the patient has shown significant improvement with the pelvic floor physical therapy, including improvement with the reported incontinence.

Manufacturer Narrative

The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The investigation of this event consisted of a review of the treatment log files, the device history record (dhr), and labeling.The aquabeam robotic system's treatment logs file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the treatment logs indicated that the system functioned as designed.A review of the device history record (dhr) ab2000-b / serial number (b)(6) was conducted, which confirmed that there were no non-conformances, 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.The aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 4.3.Warnings: procedure: as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o bleeding.A root cause for the reported event could not be determined.A cystogram procedure was performed on the patient, which revealed that the external sphincter had been injured during the aquablation procedure.A formal review of the event log files was conducted with the treating surgeon.No malfunction of the aquabeam robotic system was reported during this event.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: 16321673
• MDR Text Key: 309021182
• Report Number: 3012977056-2023-00010
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20220627S
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male