BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 18951218 · Received March 21, 2024

    Report

    Report Number
    3012977056-2024-00083
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    March 6, 2024
    Report Date
    May 3, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AQUABEAM HANDPIECE WAS NOT RETURNED FOR INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE ESTABLISHED AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AQUABEAM ROBOTIC SYSTEM/SERIAL NUMBER (B)(6) AND THE AQUABEAM HANDPIECE / LOT NUMBER 24C11890 WAS PERFORMED, WHICH CONFIRMED THAT THERE WERE 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 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. E23 - MOTORPACK ERROR: RELEASE FOOT PEDAL AND CLICK X. 1) IF ERROR PERSISTS, RECONNECT HANDPIECE TO MOTORPACK. 2) IF ERROR CONTINUES, REPLACE HANDPIECE. E31 - MOTORPACK ERROR: RELEASE FOOT PEDAL AND CLICK X. IF ERROR PERSISTS, 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 FOLLOWING THE FIRST TREATMENT PASS, THE AQUABEAM ROBOTIC SYSTEM GENERATED AN "E22 - MOTORPACK ERROR" AND "E23 - MOTORPACK ERROR" WHICH WERE CLEARED WITH SOME TROUBLESHOOTING STEPS. THE AQUABEAM ROBOTIC SYSTEM THEN GENERATED AN "E31 - MOTORPACK ERROR" WHICH COULD NOT BE CLEARED. AS A RESULT A SECOND AQUABEAM HANDPIECE WAS OPENED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. 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
    891672 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male