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 Problem Urinary Incontinence (4572)

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned for investigation nor any device information was provided to procept; therefore, no review of the device history record or log files was possible.Aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: incontinence or overactive bladder.A review of similar complaints from a period of 12-months period confirmed no other similar events have been reported to procept.A root cause for the reported event could not be determined.The aquabeam robotic system's ifu lists incontinence or overactive bladderas as potential risks of the aquablation procedure.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

On (b)(6) 2022, a patient with a long history of being in urinary retention and urinary tract infections due to the use of catheters underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).The patient had previously undergone treatment with the rezum¿ water vapor therapy, which did not alleviate the symptom.On (b)(6) 2022, the patient reported to procept biorobotics corporation experiencing urinary incontinence post-aquablation procedure.Post-void residual is reducing but the patient continues to use a catheter.The patient was advised to consult a urologist professional for further evaluation.No further details are available nor was procept biorobotics made aware of this event by the user facility.Per the manufacturer's instructions for use, incontinence or overactive bladder are perioperative risks associated with the aquablation procedure.

• 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: 14493752
• MDR Text Key: 292574045
• Report Number: 3012977056-2022-00063
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: 00+B614AB20001
• UDI-Public: +B614AB20001
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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?: 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
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Sex: Male