BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 20055496 · Received August 23, 2024

    Report

    Report Number
    3012977056-2024-00211
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    April 25, 2024
    Report Date
    October 11, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ON 06-OCT-2024, PROCEPT RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT WAS EXPERIENCING CLOTTING IN HIS CATHETER; HOWEVER, NO TAKEBACK WAS NECESSARY TO RESOLVE THE CLOTTING. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED TO ADDRESS THE REPORTED CLOTTING. BASED ON THIS ADDITIONAL INFORMATION, PROCEPT DEEMS THIS EVENT AS NON-REPORTABLE TO THE FDA.

    Description of Event or Problem · 0

    A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE AT AN UNSPECIFIED TIME POST AQUABLATION THERAPY, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR CLOT EVACUATION. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743483 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention