BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 18080832 · Received November 6, 2023

    Report

    Report Number
    3012977056-2023-00193
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 20, 2023
    Report Date
    December 8, 2023
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    00860009122918
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    05-DEC-2023 PROCEPT BIOROBOTICS RECEIVED ADDITIONAL INFORMATION THAT THE SURGICAL PROCEDURE DELAY WAS UNDER 20 MINUTES. BASED ON THIS INFORMATION, IT IS NOT CONSIDERED TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY OR OTHER SIGNIFICANT ADVERSE DEVICE EXPERIENCES REQUIRED BY REGULATION, BUT RATHER RESULT IN MINOR INCONVENIENCE.

    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 AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING TREATMENT, THE AQUABEAM ROBOTIC SYSTEM GENERATED AN "E22 - MOTORPACK ERROR" MESSAGE, WHICH WAS UNABLE TO BE CLEARED DESPITE MULTIPLE TROUBLESHOOTING STEPS TAKEN IN EFFORTS TO RESOLVE THE ISSUE. A SECOND AQUABEAM HANDPIECE WAS USED WHICH RESOLVED THE ISSUE AND THE AQUABLATION PROCEDURE WAS SUCCESSFULLY COMPLETED. THE REPORTED EVENT CAUSED A SURGICAL DELAY OF OVER 20 MINUTES. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248099 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 00860009122918

    Patients

    Seq Age Sex Outcome Treatment
    1 Male