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 Urethral Stenosis/Stricture (4501); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

H6.Clinical signs = 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.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

On (b)(6) 2023, a male patient underwent aquablation therapy for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that in (b)(6) 2024, the patient underwent a transurethral resection of the prostate (turp) procedure due to symptoms he was experiencing post aquablation therapy.It was reported that under cystoscopy, there appeared to be an adhesion near the patient's verumontanum, creating a "bridge" in the patient's prostate apex.It was reported that the patient has been discharged.No malfunction of the aquabeam robotic system was reported.

Manufacturer Narrative

H.11 additional manufacturer narrative: the aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The aquabeam robotic system's ifu lists urethral damage causing false passage or stricture as a potential risk of aquablation therapy.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 review of the event details, dhr, and ifu, the event is considered not to be device-related.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) for the aquabeam robotic system serial number 19c01641 was conducted, which confirmed that there were no non-conformances issued to this lot during the manufacturing process that could potentially be related to the reported failure.The device met all required specifications and was deemed acceptable to be 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: urethral damage causing false passage or stricture.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.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 dr; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr; san jose, CA 95134 ; 6502327291
• MDR Report Key: 19102329
• MDR Text Key: 340107800
• Report Number: 3012977056-2024-00101
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20191219S
• 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: 05/10/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/10/2024
• 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