BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 14431980 · Received May 18, 2022

    Report

    Report Number
    3012977056-2022-00055
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    January 25, 2021
    Report Date
    May 16, 2022
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B6142201011
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE AQUABEAM ROBOTIC SYSTEM'S LOG FILE COULD NOT BE CONDUCTED AS THE DATE WHEN THE AQUABLATION PROCEDURE TOOK PLACE IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR SERIAL NUMBER (B)(4) WAS PERFORMED, 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. AQUABEAM ROBOTIC SYSTEM USER MANUAL, UM220101, WAS REVIEWED AND STATES THE FOLLOWING: PROCEDURE: AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL RISKS OF THE AQUABLATION PROCEDURE INCLUDE: O BLEEDING. A HISTORICAL REVIEW FOR SIMILAR COMPLAINTS CONFIRMED NO OTHER SIMILAR EVENTS FOR DEEP VEIN THROMBOSIS HAVE BEEN REPORTED TO PROCEPT BIOROBOTICS. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE AQUABEAM ROBOTIC SYSTEM USER MANUAL LISTS BLEEDING AS A POTENTIAL RISK OF THE AQUABLATION PROCEDURE. NO DEVICE MALFUNCTION WAS REPORTED OR CONFIRMED THROUGH THE INVESTIGATION PERFORMED BY PROCEPT.

    Description of Event or Problem · 0

    ON 18-APRIL-2022, PROCEPT BIOROBOTICS CORPORATION BECAME AWARE OF AN ARTICLE PUBLISHED ON 25-JAN-2021 IN THE INVESTIGATE AND CLINICAL UROLOGY (ICUROLOGY) THAT INCLUDED DETAILS OF 14 ADVERSE EVENTS REPORTED IN PATIENTS WITHIN 90 DAYS OF UNDERGOING AN AQUABLATION PROCEDURE. MOST PROCEDURAL-RELATED ADVERSE EVENTS WERE CLASSIFIED AS CLAVIEN-DINDO GRADE 1 OR GRADE 2. THIS EVENT IS BEING SUBMITTED FOR ONE (1) OF FIVE (5) EVENTS CLASSIFIED AS CLAVIEN-DINDO 2 DUE TO DEEP VEIN THROMBOSIS (DVT) MANAGED WITH ANTICOAGULANT MEDICATION. ONE (1) OF THE FIVE (5) EVENTS WAS CLASSIFIED AS CLAVIEN-DINDO 2 DUE TO A CAPSULAR PERFORATION REQUIRING PROLONGED CATHETERIZATION OF APPROXIMATELY 20 DAYS WAS PREVIOUSLY SUBMITTED BY PROCEPT UNDER MFR. REPORT #3012977056-2020-00004; NO NEW REPORT IS REQUIRED ON THIS EVENT. NO GRADE 4B OR GRADE 5 COMPLICATIONS WERE NOTED. NO DEVICE MALFUNCTION WAS REPORTED DURING THESE PROCEDURES. THE MANUFACTURER'S USER MANUAL LIST BLEEDING AS A POTENTIAL RISK OF THE AQUABLATION PROCEDURE. ALL PERTAINING INFORMATION AVAILABLE TO PROCEPT BIOROBOTIC IS BEING SUBMITTED WITH THIS REPORT. THIS IS REPORT 9 OF 13.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2639179 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B6142201011

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention