BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 18700369 · Received February 13, 2024

    Report

    Report Number
    3012977056-2024-00033
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 23, 2024
    Report Date
    March 11, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AQUABEAM HANDPIECE WAS RETURNED FOR INVESTIGATION. FUNCTIONAL TESTING WAS UNABLE TO REPLICATE THE E22 ERROR. THE ROOT CAUSE OF THE REPORTED ERROR IS UNDETERMINABLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AB2000-B / SERIAL NUMBER (B)(6) AND AQUABEAM HANDPIECE / LOT NUMBER 23C03489 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 EVENT. THE AFFECTED UNITS WITHIN THE LOT WERE SEGREGATED AND REWORKED TO ADDRESS THE NON-CONFORMANCES. THE HANDPIECE PASSED FINAL INSPECTION PRIOR TO RELEASE FOR DISTRIBUTION. THE AQUABEAM ROBOTIC SYSTEM USER MANUAL, UM0101 REV. F, STATES THE FOLLOWING: 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 INVESTIGATION INTO THIS ISSUE HAS CONFIRMED THE OCCURRENCE OF "E22 - MOTORPACK" ERRORS. THE ISSUE IS BEING ADDRESSED THROUGH PROCEPT'S QUALITY SYSTEM. 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 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 THE AQUABLATION PROCEDURAL SETUP, AN "E22. MOTORPACK ERROR" WAS GENERATED BY THE AQUABEAM ROBOTIC SYSTEM. MULTIPLE TROUBLESHOOTING STEPS WERE PERFORMED WHICH WERE UNABLE TO RESOLVE THE ERROR. A SECOND AQUABEAM HANDPIECE WAS USED AND AN "E22. MOTORPACK ERROR" WAS GENERATED BY THE AQUABEAM ROBOTIC SYSTEM. A THIRD AQUABEAM HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.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
    81114 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male