BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 19756645 · Received July 16, 2024

    Report

    Report Number
    3012977056-2024-00179
    Event Type
    Death
    Date Received
    July 16, 2024
    Date of Event
    June 26, 2024
    Report Date
    August 30, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    00850055427020
    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

    H11. ADDITIONAL MANUFACTURER NARRATIVE: A2. THE PATIENT'S AGE IS UNKNOWN. B3. PROCEPT'S AWARENESS DATE OF THE EVENT IS BEING USED, AS THE EXACT DATE OF THE PATIENT DEATH IS UNKNOWN. 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 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), 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. 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 EMBOLISM. IT WAS REPORTED THAT POST-AQUABLATION THERAPY, THE PATIENT WAS FOUND TO HAVE BLADDER CANCER AFTER EXPERIENCING PROLONGED HEMATURIA. THE PATIENT WAS ENCOURAGED TO HAVE AN INFERIOR VENA CAVA (IVC) FILTER PLACED AND TO HAVE HIS BLADDER REMOVED. WHILE WAITING FOR HIS BLADDER REMOVAL SURGERY, A CLOT PASSED THROUGH THE PATIENT'S IVC FILTER, TO HIS HEART. THE PATIENT EXPERIENCED CARDIAC ARREST AND SUBSEQUENTLY EXPIRED. IT WAS REPORTED THAT NO ISSUES WERE EXPERIENCED DURING AQUABLATION THERAPY AND THAT THE TREATING SURGEON DOES NOT ATTRIBUTE THE EVENT TO AQUABLATION THERAPY. BASED ON THE INFORMATION OBTAINED THROUGH THE TREATING SURGEON, PLUS A REVIEW OF THE DHR AND IFU, THE EVENT IS CONSIDERED NOT 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

    A MALE PATIENT UNDERWENT AQUABLATION THERAPY ON (B)(6) 2024 FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT AT AN UNSPECIFIED TIME POST-AQUABLATION THERAPY, THE PATIENT WAS FOUND TO HAVE BLADDER CANCER AFTER EXPERIENCING PROLONGED HEMATURIA. THE PATIENT WAS OPPOSED TO REMOVING HIS BLADDER AND OPTED FOR CHEMOTHERAPY AND RADIATION. THE PATIENT CONTINUED TO EXPERIENCE HEMATURIA AND WAS ENCOURAGED TO HAVE AN INFERIOR VENA CAVA (IVC) FILTER PLACED AND TO HAVE HIS BLADDER REMOVED. WHILE WAITING FOR HIS BLADDER REMOVAL SURGERY, A CLOT PASSED THROUGH THE PATIENT'S IVC FILTER, TO HIS HEART. THE PATIENT EXPERIENCED CARDIAC ARREST AND SUBSEQUENTLY EXPIRED. THE TREATING SURGEON DOES NOT ATTRIBUTE THE EVENT TO AQUABLATION THERAPY AND IS NOT INTERESTED IN DISCUSSING THIS EVENT ANY FURTHER. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT THERE WERE NO ISSUES EXPERIENCED DURING THE PATIENT'S AQUABLATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509377 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 00850055427020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death