BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 20579574 · Received October 31, 2024

    Report

    Report Number
    3012977056-2024-00255
    Event Type
    Death
    Date Received
    October 31, 2024
    Date of Event
    October 5, 2024
    Report Date
    December 11, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    00850055427020
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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

    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 TREATMENT LOG FILES, DEVICE HISTORY RECORD (DHR), AND INSTRUCTIONS FOR USE (IFU). THE AQUABEAM ROBOTIC SYSTEM'S TREATMENT LOG FILES WERE REVIEWED, WHICH CONFIRMED NO MALFUNCTION OCCURRED. THE REVIEW OF THE TREATMENT LOG FILES REVEALED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AS NO MALFUNCTION WAS OBSERVED DURING AQUABLATION THERAPY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-D/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), SJ-IFU0101-00, REV. B, 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. THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. IT WAS REPORTED THAT THE PATIENT PAST AWAY POST AQUABLATION THERAPY AFTER BEING DISCHARGED HOME. IT WAS REPORTED THAT THE PATIENT RECEIVED CARDIAC AND ANESTHESIA CLEARANCE FOR AQUABLATION THERAPY. THE CAUSE OF DEATH IS UNKNOWN. THE TREATING SURGEON DID NOT HAVE ANY FURTHER DETAILS. 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 ON (B)(6) 2024 FOR SYMPTOMATIC BENIGN PROSTATE HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT AFTER DISCHARGE FROM THE HOSPITAL, THE PATIENT PASSED AWAY AT HOME. THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT RECEIVED CARDIAC AND ANESTHESIA CLEARANCE PRIOR TO AQUABLATION THERAPY. IT WAS REPORTED BY THE TREATING SURGEON THAT AN AUTOPSY WILL BE CONDUCTED. MULTIPLE FOLLOW-UP ATTEMPTS HAVE BEEN MADE WITH THE TREATING SURGEON FOR ADDITIONAL DETAILS; HOWEVER, HE DOES NOT HAVE ANY ADDITIONAL INFORMATION AT THIS TIME. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896973 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 00850055427020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death