BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 18480373 · Received January 9, 2024

    Report

    Report Number
    3012977056-2024-00010
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 26, 2023
    Report Date
    March 1, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AQUABEAM HANDPIECE WAS NOT RETURNED FOR INVESTIGATION AS IT WAS DISPOSED OF AT THE USER FACILITY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AB2000-B / SERIAL NUMBER (B)(6) AND AQUABEAM HANDPIECE / LOT NUMBER 23C04637 WAS CONDUCTED, WHICH CONFIRMED THAT THERE WAS TWO (2) NON-CONFORMANCES ISSUED TO THIS LOT DURING THE MANUFACTURING PROCESS THAT COULD POTENTIALLY BE RELATED TO THE REPORTED EVENT. THE AFFECTED UNITS WITHIN THE LOT WERE REWORKED TO ADDRESS THE NONCONFORMANCE. UPON RE-INSPECTION, THE LOT MET ALL REQUIRED SPECIFICATIONS AND WAS THEN DEEMED ACCEPTABLE TO BE RELEASED FOR DISTRIBUTION PER DEVICE SPECIFICATIONS. THE CURRENT USER MANUAL SJ-UM0101-00 REV. B, UM, AQUABEAM ROBOTIC SYSTEM USER MANUAL, US, BAYTECH, ENGLISH WAS REVIEWED. TABLE 5: SYSTEM DETECTED ERRORS AND FAULTS E22 - MOTORPACK ERROR RELEASE FOOT PEDAL AND CLICK X. 1) IF ERROR PERSISTS, RECONNECT HANDPIECE TO MOTORPACK. 2) IF ERROR CONTINUES, REPLACE HANDPIECE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE ESTABLISHED AS THE HANDPIECE WAS NOT RETURNED FOR INVESTIGATION. 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 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 BECAME AWARE THAT NEAR THE END OF THE FIRST TREATMENT PASS, THE AQUABEAM ROBOTIC SYSTEM GENERATED AN "E22 - MOTORPACK ERROR." MULTIPLE TROUBLESHOOTING ATTEMPTS WERE MADE, AND SLIGHT TORQUE WAS TAKEN OFF THE HANDPIECE SHAFT. THE CONTOUR WAS REPLANNED, BUT THE ISSUE PERSISTED AT THE START OF THE SECOND TREATMENT PASS. AS A RESULT, THE AQUABLATION PROCEDURE WAS ABORTED, AND THE TREATING SURGEON ELECTED TO PROCEED WITH CAUTERY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650963 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male