BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 17195245 · Received June 23, 2023

    Report

    Report Number
    3012977056-2023-00106
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    June 14, 2023
    Report Date
    September 21, 2023
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AQUABEAM HANDPIECE WAS DELIVERED AT THE HEADQUARTERS LOCATION ACCORDING TO THE TRACKING NUMBER; HOWEVER, THE DEVICE CANNOT BE LOCATED POST-RECEIPT BY PROCEPT PERSONNEL. THE AQUABEAM ROBOTIC SYSTEM'S TREATMENT LOGS FILE WAS REVIEWED, WHICH CONFIRMED THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AB2000-B / SERIAL NUMBER (B)(6) AND AQUABEAM HANDPIECE / LOT NUMBER 23C00626 WAS CONDUCTED, 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 CURRENT USER MANUAL UM0104-00 REV. G, AQUABEAM ROBOTIC SYSTEM USER MANUAL 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. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE ESTABLISHED AS THE HANDPIECE WAS PHYSICALLY UNAVAILABLE 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 (PROCEPT) BECAME AWARE DURING THE AQUABLATION PROCEDURE AFTER CONNECTING THE AQUABEAM HANDPIECE TO THE AQUABEAM MOTORPACK AN "E22 - MOTORPACK ERROR" WAS GENERATED BY THE AQUABEAM ROBOTIC SYSTEM. A SECOND HANDPIECE WAS USED TO RESOLVE THE ISSUE, BUT THE ERROR PERSISTED. AS A RESULT, A THIRD HANDPIECE UNIT WAS USED 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
    854887 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male