BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 14317747 · Received May 7, 2022

    Report

    Report Number
    3012977056-2022-00039
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    March 9, 2022
    Report Date
    May 6, 2022
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    00+B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION NOR ANY DEVICE INFORMATION WAS PROVIDED TO PROCEPT; THEREFORE, NO REVIEW OF THE DEVICE HISTORY RECORD OR LOG FILES WAS POSSIBLE. AQUABEAM ROBOTIC SYSTEM INSTRUCTIONS FOR USE (IFU), IFU0101-00, REV. E, WAS REVIEWED AND STATES THE FOLLOWING: WARNINGS: PROCEDURE AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE: O BLEEDING. A REVIEW OF SIMILAR COMPLAINTS FROM A PERIOD OF 12 MONTHS CONFIRMED A TOTAL OF 11 SIMILAR EVENTS HAVE BEEN REPORTED TO PROCEPT. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE AQUABEAM ROBOTIC SYSTEM'S IFU LISTS BLEEDING AS A POTENTIAL RISK OF THE AQUABLATION PROCEDURE. 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

    PER A USER FACILITY VOLUNTARY REPORT SUBMITTED THROUGH THE FDA'S MEDWATCH PROGRAM, PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA (BPH) IN (B)(6) 2022. THE PATIENT WAS DISCHARGED HOME AND RETURNED TO THE EMERGENCY ROOM WITH URINARY CLOT RETENTION AND REQUIRED OPERATIVE INTERVENTION WITH CYSTOSCOPY, CLOT EVACUATION, AND FULGURATION OF BLEEDING VESSELS AT THE BLADDER NECK. NO ADVERSE HEALTH CONSEQUENCES WERE REPORTED DUE TO THE REPORTED EVENT. NO FURTHER DETAILS WERE PROVIDED NOR WAS PROCEPT BIOROBOTICS MADE AWARE OF THIS EVENT BY THE USER FACILITY. PER THE MANUFACTURER'S INSTRUCTIONS FOR USE, BLEEDING IS A PERIOPERATIVE RISK ASSOCIATED WITH THE AQUABLATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233344 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 00+B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention