BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 18981835 · Received March 26, 2024

    Report

    Report Number
    3012977056-2024-00087
    Event Type
    Death
    Date Received
    March 26, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 30, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM PROCEPT SALES REPRESENTATIVE ON 03-APR-2024 INDICATING THAT HE DOES NOT KNOW IF AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT THE TREATING SURGEON WAS NOT INTERESTED IN DISCUSSING FURTHER. ON 08-APR-2024, ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE INDICATING THAT THE PHYSICIAN WAS UNABLE TO PROVIDE PATIENT DETAILS WHEN REQUESTED. 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), IFU0101-00, REV. E, WAS REVIEWED AND STATES THE FOLLOWING: 3. CONTRAINDICATIONS DO NOT USE THE AQUABEAM ROBOTIC SYSTEM IN PATIENTS WHO DO NOT MEET THE INDICATION FOR THE SYSTEM'S INTENDED USE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CARDIAC EVENT AFTER BEING DISCHARGED. THE PATIENT REFUSED NECESSARY TREATMENT FOR THE CARDIAC EVENT, AND SUBSEQUENTLY PASSED AWAY. IT WAS CONFIRMED THROUGH THE TREATING SURGEON THAT THE PATIENT'S DEATH WAS UNRELATED TO THE AQUABLATION PROCEDURE. 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 INSTRUCTIONS FOR USE. 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.

    Additional Manufacturer Narrative · 0

    ROOT CAUSE OF 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.

    Description of Event or Problem · 0

    IN (B)(6) 2023, A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). IT WAS REPORTED THAT THE AQUABLATION PROCEDURE WENT AS PLANNED, AND THE PATIENT WAS DISCHARGED HOME. ON MARCH 11, 2024, PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT POST-DISCHARGE, THE PATIENT EXPIRED DUE TO A CARDIAC EVENT. THE PATIENT REFUSED NECESSARY TREATMENT FOR THE CARDIAC EVENT DUE TO RELIGIOUS REASONS AND PASSED AWAY AS A RESULT THEREAFTER. ON MARCH 13, 2024, THROUGH A FOLLOW-UP WITH THE TREATING SURGEON, IT WAS CONFIRMED THAT THE PATIENT PRESENTED NO POSTOPERATIVE SYMPTOMS TO INDICATE ANY COMPLICATIONS AND THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED AND DEEMED THE EVENT UNRELATED TO THE AQUABLATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death