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 Bacterial Infection (1735)

Event Date 09/23/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for investigation because it is a reusable component, which is still being used at 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) 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) - japan, ifu0107-00, rev.A, was reviewed and states the following: 4.3.Warnings: procedure.As with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include but are not limited to the following, some of which may lead to serious outcomes and may require intervention: o infection investigation of the dhr, labeling/ifu, and information received through the treating surgeon confirmed that no device malfunction occurred and the aquabeam robotic system functioned as intended and was used in accordance with its ifu.The reported event was determined 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).Procept biorobotics corporation (procept) became aware the patient had presented with bilateral epididymitis (per manufacturer's instructions for use, infection is a perioperative risk of the aquablation procedure).As a result, the patient was catheterized and given medication which resolved the infection.The event was reported to be moderate and serious.No malfunction of the aquabeam robotic system was 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 drive; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech drive; san jose, CA 95134
• MDR Report Key: 18384331
• MDR Text Key: 331296625
• Report Number: 3012977056-2023-00234
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: 00860009122918
• UDI-Public: 010086000912291811230425
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,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: 11/23/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2023
• 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