BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 21637038 · Received March 18, 2025

    Report

    Report Number
    3012977056-2025-00083
    Event Type
    Death
    Date Received
    March 18, 2025
    Date of Event
    February 20, 2025
    Report Date
    April 8, 2025
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-B/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 DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE AQUABEAM ROBOTIC SYSTEM INSTRUCTIONS FOR USE (IFU), IFU0101-00, REV. E, WAS REVIEWED. 3. CONTRAINDICATIONS: DO NOT USE THE AQUABEAM ROBOTIC SYSTEM IN PATIENTS WHO DO NOT MEET THE INDICATION FOR THE SYSTEM¿S INTENDED USE. THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. IT WAS REPORTED THAT THE PATIENT PASSED AWAY A FEW DAYS POST AQUABLATION THERAPY. THE TREATING SURGEON CONFIRMED THAT THE PATIENT HAD UNDISCLOSED PRE-EXISTING CONDITIONS THAT POSSIBLY ATTRIBUTED TO THE PATIENT'S DEATH. THE CAUSE OF DEATH REMAINS UNKNOWN AS THE TREATING SURGEON DID NOT PROVIDE ANY FURTHER DETAILS DUE TO THE SENSITIVE NATURE OF THE EVENT DESPITE MULTIPLE ATTEMPTS TO OBTAIN INFORMATION SUCH AS CAUSE OF DEATH AND RELATIONSHIP TO THE DEVICE OR PROCEDURE. SHALL NEW INFORMATION BECOMES AVAILABLE IN THE FUTURE, THEN FURTHER INVESTIGATION WILL BE CONDUCTED. 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 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.

    Description of Event or Problem · 0

    A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT AFTER AQUABLATION THERAPY AND DURING FOCAL BLADDER NECK CAUTERY, THE PATIENT CODED. THE PATIENT WAS RESUSCITATED AND TRANSPORTED TO INTERVENTIONAL RADIOLOGY WHERE UNSPECIFIED MEDICAL INTERVENTION WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT PASSED AWAY THE WEEKEND AFTER HIS AQUABLATION THERAPY. THE TREATING SURGEON REPORTED THAT THE PATIENT'S CARDIAC ARREST MAY HAVE BEEN RELATED TO UNSPECIFIED PRE-EXISTING MEDICAL CONDITIONS. PROCEPT HAS MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL DETAILS REGARDING THE PATIENT'S DEATH; HOWEVER, TO DATE, NO ADDITIONAL DETAILS HAVE BEEN RECEIVED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15899 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death| O| D| O