BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 11606515 · Received April 1, 2021

    Report

    Report Number
    3012977056-2021-00015
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 3, 2021
    Report Date
    May 24, 2021
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H11. CORRECTED DATA: H3. DEVICE EVALUATION BY MANUFACTURER: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE AQUABEAM CONSOLE AND AQUABEAM ROBOTIC SYSTEM, WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE DEVICES MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    H3: DEVICE EVALUATION BY MANUFACTURER: THE AQUABEAM CONSOLE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION CONFIRMED THAT THE LEVELER WAS ATTACHED TO ONE OF THE MIDDLE LEGS OF THE CONSOLE. THE PUMP CARTRIDGE LATCH WAS IN A PERMANENT LOCKED POSITION AND FAILED TO TRANSITION TO AN UNLOCK POSITION. THE PUMP CARTRIDGE HOUSING INSIDE THE CONSOLE WAS INSPECTED AND REMOVED TO INSPECT THE HELICAL GEAR. THE HELICAL GEAR WAS SHATTERED WITHIN THE PUMP CARTRIDGE HOUSING. THE SHATTERING WAS DUE TO IMPROPER ORIENTATION OF THE TWO (2) HELICAL GEARS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE AQUABEAM HANDPIECE AND AQUABEAM ROBOTIC SYSTEM, WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. A REVIEW FOR SIMILAR COMPLAINTS CONFIRMED THAT THERE ARE NO OTHER SIMILAR EVENTS THAT HAVE BEEN REPORTED TO PROCEPT BIOROBOTICS. THE AQUABEAM ROBOTIC SYSTEM'S USER MANUAL, UM0101-00 REV. E, WAS REVIEWED AND STATES THE FOLLOWING: TABLE 4 AQUABEAM ROBOTIC SYSTEM STATUS INDICATIONS CONFIRM CARTRIDGE IS FULLY SEATED INTO PUMP HEAD AND CLOSE LATCH (NOTE: LATCH PROVIDES A TACTILE CLICK UPON CLOSURE). THE REPORTED FAILURE MODE WAS CONFIRMED DURING FUNCTIONAL TESTING. THE PUMP CARTRIDGE LATCH WAS STUCK IN THE LOCK POSITION AND WAS UNABLE TO BE UNLOCKED. THE ANALYSIS CONFIRMED A BROKEN HELICAL GEAR, WHICH WAS CAUSED BY IMPROPER ORIENTATION OF THE TWO (2) HELICAL GEARS. PROCEPT IMPLEMENTED AN INSPECTION PROCESS TO ENSURE PROPER ORIENTATION BETWEEN THE TWO (2) HELICAL GEARS DURING THE MANUFACTURING PROCESS OF THE AQUABEAM CONSOLE. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT PROBLEM: (B)(4): AQUABEAM CONSOLE, A REUSABLE COMPONENT OF THE AQUABEAM ROBOTIC SYSTEM, CONTROLS THE FUNCTIONALITY OF THE HIGH-VELOCITY WATERJET DELIVERED BY THE AQUABEAM HANDPIECE. THE AQUABEAM CONSOLE HAS BEEN RETURNED TO THE MANUFACTURER; HOWEVER, INVESTIGATION 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 · 1

    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 HANDPIECE PUMP CARTRIDGE WAS UNABLE TO BE LATCHED TO THE AQUABEAM CONSOLE. MULTIPLE TROUBLESHOOTING STEPS WERE UNABLE TO RESOLVE THE ISSUE AND THE AQUABLATION PROCEDURE WAS ABORTED. THE PATIENT WAS ALREADY UNDER SEDATION WHEN THE EVENT OCCURRED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES WITH THE PATIENT BECAUSE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501973 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1