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

Catalog Number AB2000

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

Patient Problems Bacterial Infection (1735); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/23/2023

Event Type  Injury  

Manufacturer Narrative

H6: health effect - clinical code.4581 - lower urinary tract symptoms (luts) are a common complaint among aging men.These symptoms are often caused by benign prostatic hyperplasia (bph), and include nocturia, urinary frequency, urgency, decreased urine flow rates, incomplete bladder emptying, and hesitancy.H10: additional narrative/data.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 labeling.A device history record (dhr) review is unable to be performed as the aquabeam robotic system serial number is unknown.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 infection.5.1 precautions: general.No claim is made that the aquabeam robotic system will cure any medical condition or entirely eliminate the diseased entity.Repeated treatment or alternative therapies may sometimes be required.A root cause for the reported event could not be determined.The aquabeam robotic system user manual lists infection as a potential risk of the aquablation procedure.Additionally, the aquabeam robotic system does not guarantee the cure of any medical condition or entire elimination of diseased entity.Repeated treatment or alternative therapies may sometimes be required.Based on the event details plus a review of the labeling, the event is considered not to be device-related.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

In (b)(6) 2023, a male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).On (b)(6) 2023, the patient reported to procept biorobotics corporation experiencing a bladder infection post-aquablation procedure and ended up in the emergency room.The patient reported experiencing back pain and indicated that magnetic resonance imaging (mri) and bloodwork confirmed an enterococcus infection at the base of the spine.The patient was treated with intravenous antibiotics for 7 weeks to resolve the infection.The patient also reported experiencing a slow urine flow and an ultrasound showed that the prostate is still enlarged.A urologist attempted to scope the patient but was unsuccessful due to scar tissue encountered while attempting to reach the bladder.The patient reported having surgery "in a couple of weeks" to resolve the scar tissue.No further details were provided by the patient nor was procept able to determine where the patient underwent the aquablation therapy.

• 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
• MDR Report Key: 18414744
• MDR Text Key: 331577849
• Report Number: 3012977056-2023-00248
• Device Sequence Number: 1
• Product Code: PZP
• Combination Product (y/n): N
• 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: 12/28/2023

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 Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male