BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 14350001 · Received May 10, 2022

    Report

    Report Number
    3012977056-2022-00045
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    May 20, 2021
    Report Date
    May 10, 2022
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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) REV. B/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 INSTRUCTIONS FOR USE (IFU), IFU0101-00, REV. E, WAS REVIEWED AND STATES THE FOLLOWING: 4.3. WARNINGS: PROCEDURE AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE: O INFECTION. A 12TH-MONTH REVIEW FOR SIMILAR COMPLAINTS UNDER (B)(4) REV. B/SERIAL NUMBER (B)(4) CONFIRMED THREE (3) SIMILAR EVENTS FOR URINARY TRACT INFECTION HAVE BEEN REPORTED TO PROCEPT BIOROBOTICS. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE AQUABEAM ROBOTIC SYSTEM INSTRUCTIONS FOR USE LISTS INFECTION AS A POTENTIAL RISK OF THE AQUABLATION PROCEDURE. NO DEVICE MALFUNCTION WAS REPORTED OR CONFIRMED THROUGH THE INVESTIGATION PERFORMED BY PROCEPT. 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

    ON 18-APRIL-2022, PROCEPT BIOROBOTICS CORPORATION BECAME AWARE OF AN ARTICLE PUBLISHED ON 20-MAY-2021 IN THE CENTRAL EUROPEAN JOURNAL OF UROLOGY THAT INCLUDED DETAILS OF TWO (2) CASES OF LOW-GRADE CLAVIEN COMPLICATIONS POST COMBINATION OF WATERJET ABLATION (AQUABEAM ROBOTIC SYSTEM) AND HOLMIUM LASER POWER FOR TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA. IN ONE CASE, THE EVENT PRESENTED WITH URINARY TRACT INFECTION AND THE OTHER ONE WITH MILD HEMATURIA, WHICH WERE MANAGED WITH ORAL ANTIBIOTICS AND BLADDER IRRIGATION LASTING LESS THAN 24 HOURS, RESPECTIVELY (PER THE MANUFACTURER'S INSTRUCTIONS FOR USE, INFECTION AND BLEEDING ARE LISTED AS PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE). NO DEVICE MALFUNCTION WAS REPORTED DURING THESE PROCEDURES. ALL PERTAINING INFORMATION AVAILABLE TO PROCEPT BIOROBOTIC IS BEING SUBMITTED WITH THIS REPORT. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2276938 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention