BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 24678177 · Received March 24, 2026

    Report

    Report Number
    3012977056-2026-00052
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 24, 2026
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    00850055427037
    PMA / PMN Number
    DEN170024
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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.

    Description of Event or Problem · 0

    A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY, THE AQUABEAM ROBOTIC SYSTEM GENERATED MULTIPLE INSTANCES OF AN "E03 - CONSOLE ERROR." DESPITE TROUBLESHOOTING ATTEMPTS, THE ERRORS PERSISTED AND COULD NOT BE RESOLVED. THE TREATING SURGEON ULTIMATELY MADE THE DECISION TO ABORT AQUABLATION THERAPY AND CONVERTED TO A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) SURGERY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734083 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 00850055427037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male