BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 17400413 · Received July 26, 2023

    Report

    Report Number
    3012977056-2023-00118
    Event Type
    Death
    Date Received
    July 26, 2023
    Date of Event
    June 27, 2023
    Report Date
    September 12, 2023
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION BECAUSE IT IS A REUSABLE COMPONENT, WHICH IS STILL BEING USED AT THE USER FACILITY. THE INVESTIGATION OF THIS EVENT CONSISTED OF A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND LABELING. 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. 4.3. WARNINGS: PROCEDURE. AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE: O EMBOLISM. 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 IFU. 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

    A MALE PATIENT UNDERWENT AN UNEVENTFUL AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT POST AQUABLATION PROCEDURE AND WHILE IN THE PROCESS OF BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT BEGAN HAVING DIFFICULTY BREATHING, CODED, AND EXPIRED THEREAFTER. POST AQUABLATION PROCEDURE, IT WAS REPORTED THAT THE PATIENT'S VITAL SIGNS REMAINED STABLE DURING THE TIME IN THE POST-ANESTHESIA CARE UNIT (PACU) AND ON THE HOSPITAL FLOOR. AFTER THE CATHETER'S REMOVAL, THE PATIENT WAS ABLE TO WALK AROUND AND REQUESTED TYLENOL FOR MILD PAIN. ON 29-JUN-2023, PROCEPT CONFIRMED THROUGH THE TREATING SURGEON THAT THE PATIENT'S DEATH WAS ATTRIBUTED TO A PULMONARY EMBOLISM, AND WAS UNRELATED TO THE AQUABLATION PROCEDURE. NO AUTOPSY WAS PERFORMED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813585 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death