BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 18682532 · Received February 10, 2024

    Report

    Report Number
    3012977056-2024-00023
    Event Type
    Injury
    Date Received
    February 10, 2024
    Date of Event
    November 13, 2023
    Report Date
    February 13, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    00860009122918
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL MANUFACTURER NARRATIVE ON 12-FEB-2024, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE SURGICAL INTERVENTION PERFORMED WAS URETERAL DILATION USING URETHRAL BOUGIE. THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE IT IS CURRENTLY IN THE POSSESSION OF THE USER FACILITY. THE INVESTIGATION OF THIS EVENT CONSISTED OF A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND INSTRUCTIONS FOR USE (IFU). 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: - URETHRAL DAMAGE CAUSING FALSE PASSAGE OR STRICTURE. THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION BECAUSE IT PERFORMED AS INTENDED DURING THE AQUABLATION PROCEDURE. THE AQUABEAM ROBOTIC SYSTEM INSTRUCTIONS FOR USE LISTS URETHRAL DAMAGE CAUSING FALSE PASSAGE OR STRICTURE AS A POTENTIAL RISK OF THE AQUABLATION PROCEDURE. BASED ON THE 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.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THE PATIENT HAD PRESENTED WITH A URINARY STRICTURE WHICH WAS TREATED WITH AN UNSPECIFIED SURGICAL INTERVENTION. THE EVENT WAS REPORTED TO BE SERIOUS AND HAS RESOLVED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60223 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 00860009122918

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other