BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 11606516 · Received April 1, 2021

    Report

    Report Number
    3012977056-2021-00016
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    March 10, 2021
    Report Date
    May 28, 2021
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.10 ADDITIONAL MANUFACTURER NARRATIVE: THE AQUABEAM ROBOTIC SYSTEM'S LOG FILE WAS REVIEWED, WHICH CONFIRMED NO MALFUNCTIONS DURING THE AQUABLATION PROCEDURE. THE REVIEW OF THE LOG FILE INDICATED THAT THE SYSTEM FUNCTIONED AS DESIGNED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-B REV G/SERIAL NUMBER (B)(6) WAS PERFORMED, WHICH CONFIRMED THAT NO NONCONFORMANCES WERE GENERATED DURING THE MANUFACTURING PROCESS OF THIS DEVICE. THE REVIEW INDICATED THAT THE DEVICE MET ALL REQUIRED SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A REVIEW FOR SIMILAR COMPLAINTS UNDER AB2000-B REV G/LOT NUMBER (B)(6) CONFIRMED NO OTHER SIMILAR EVENTS. A REVIEW OF SIMILAR COMPLAINTS ACROSS ALL OTHER SYSTEMS CONFIRMED 20 OTHER SIMILAR EVENTS REPORTED TO PROCEPT BIOROBOTICS. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTIONS FOR USE (IFU), IFU0104-00, REV. B, WAS REVIEWED AND STATES THE FOLLOWING: 4.3. WARNINGS: PROCEDURE AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE: O BLEEDING 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. BASED ON THE REVIEW OF THE LOG FILE, DHR AND IFU, THE EVENT IS CONSIDERED 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 · 1

    THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION AS IT IS CURRENTLY IN USE AT THE USER FACILITY. INVESTIGATION BY MANUFACTURER IS CURRENTLY IN-PROCESS.

    Description of Event or Problem · 1

    A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT POST-AQUABLATION PROCEDURE THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) DUE TO BLEEDING, WHICH WAS ADDRESSED BY PERFORMING CAUTERIZATION (PER MANUFACTURER'S INSTRUCTIONS FOR USE, BLEEDING IS A POTENTIAL PERIOPERATIVE RISK OF THE AQUABLATION PROCEDURE). THERE WERE NO ADVERSE HEALTH CONSEQUENCES REPORTED WITH THE PATIENT DUE TO THIS EVENT. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501974 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention