BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 18942409 · Received March 20, 2024

    Report

    Report Number
    3012977056-2024-00077
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    November 27, 2023
    Report Date
    May 14, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.11 ADDITIONAL MANUFACTURER NARRATIVE: THE AQUABEAM HANDPIECE WAS RETURNED INVESTIGATION. NO VISUAL DEFECTS OR ANOMALIES WERE OBSERVED WITH THE HANDPIECE. DURING FUNCTIONAL TESTING THE HANDPIECE TRIGGERED AN E22 ERROR DURING THE AQUABLATION AND COULD BE CLEARED AND A FULL AQUABLATION SIMULATION COULD BE CONDUCTED. REPORTED FAILURE MODE WAS CONFIRMED. THE HANDPIECE WAS DECONSTRUCTED AND VIEWED UNDER MAGNIFICATION. NO SIGNS OF FLUID INGRESS WERE OBSERVED ON THE SENSOR BOARD AND THE ENCODER WHEEL. THE ROOT CAUSE OF THE REPORTED FAILURE MODE IS DUE TO THE MALFUNCTION OF THE PCB BOARD. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE AQUABEAM ROBOTIC SYSTEM/SERIAL NUMBER (B)(6) AND AQUABEAM HANDPIECE/ LOT NUMBER 23C03359 WAS CONDUCTED, WHICH CONFIRMED THAT THERE WAS ONE (1) NON-CONFORMANCE ISSUED TO THIS LOT DURING THE MANUFACTURING PROCESS THAT COULD POTENTIALLY BE RELATED TO THE REPORTED FAILURE. THE LOT WAS SEGREGATED AND AFFECTED UNITS WERE REWORKED AND RE-INSPECTED AS PART OF OUR HANDPIECE FINAL INSPECTION PROCESS. UPON RE-INSPECTION, THE LOT MET ALL REQUIRED SPECIFICATIONS AND WAS DEEMED ACCEPTABLE TO BE RELEASED FOR DISTRIBUTION. THE CURRENT USER MANUAL UM0104-00 REV. G, AQUABEAM ROBOTIC SYSTEM USER MANUAL, INTL (CE), 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. 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 DURING THE AQUABLATION PROCEDURE, THE AQUABEAM ROBOTIC SYSTEM GENERATED AN "E22 - MOTORPACK ERROR". THREE OTHER AQUABEAM HANDPIECES WERE OPENED, BUT THE ISSUE PERSISTED. AS A RESULT THE AQUABLATION PROCEDURE WAS ABORTED AND CONVERTED TO TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) SURGERY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493947 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male