BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 19001093 · Received March 28, 2024

    Report

    Report Number
    3012977056-2024-00078
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 28, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    12309232123C03
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AQUABEAM ROBOTIC SYSTEM WAS NOT RETURNED, AND IT IS CURRENTLY IN USE AT THE USER FACILITY. THE INVESTIGATION OF THIS EVENT IS BASED ON THE INFORMATION RECEIVED, PLUS A REVIEW OF THE DEVICE HISTORY RECORD, AND IFU. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-B REV. G/SERIAL NUMBER (B)(6) WAS PERFORMED, WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES, 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'S INSTRUCTIONS FOR USE (IFU), IFU0101-00, REV. E, WAS REVIEWED AND STATES THE FOLLOWING: 4.3. WARNINGS: PROCEDURE. AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE: BLEEDING. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE PATIENT WAS TAKEN BACK TO THE OR FOR POST PROCEDURAL BLEEDING. THE AQUABEAM ROBOTIC SYSTEM INSTRUCTIONS FOR USE LIST BLEEDING AS A POTENTIAL RISK OF THE AQUABLATION PROCEDURE AND PROVIDES ADEQUATE INSTRUCTIONS ON HOW TO ACHIEVE APPROPRIATE HEMOSTASIS. BASED ON THE REVIEW OF THE INFORMATION PROVIDED, PLUS A REVIEW OF THE DHR AND IFU, THIS 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 · 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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT POST AQUABLATION PROCEDURE, THE PATIENT WAS TAKEN BACK TO THE OPERATION ROOM TO ADDRESS BLEEDING. THE TREATING SURGEON SPENT APPROXIMATELY 10-15 MINUTES UNROOFING CLOTS CIRCUMFERENTIALLY AT THE BLADDER NECK TO HELP IDENTIFY ANY BLEEDING ARTERIES. IT WAS REPORTED THAT A MILD BLEED LOCATED AT 6 O'CLOCK ON THE BLADDER NECK WAS MOST LIKELY THE CAUSE OF THE BLEEDING. THE BLEEDING WAS ADDRESSED WITH CAUTERY. IT WAS REPORTED THAT THE PATIENT IS CURRENTLY DOING GREAT AND HAS BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2589120 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 12309232123C03

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention