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 Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/30/2023

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 device history record (dhr), and labeling.A review of the device history record (dhr) for serial number (b)(6) was performed, 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: 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 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 dhr, and ifu 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

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph) on (b)(6)2019.On (b)(6) 2023, procept biorobotics corporation (procept) became aware that due to residual adenoma, the patient underwent an aquablation retreatment.No malfunctions of the aquabeam robotic system were reported.

• 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 dr; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr; san jose, CA 95134 ; 6502327291
• MDR Report Key: 18387080
• MDR Text Key: 331284925
• Report Number: 3012977056-2023-00249
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/$$718C00487/16D20190604X
• 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
• Report Date: 12/22/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2019
• 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