BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM

    MDR report key: 23375417 · Received October 23, 2025

    Report

    Report Number
    3012977056-2025-00273
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    July 28, 2025
    Report Date
    October 23, 2025
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENT CO. LT
    Product Code
    IYN
    UDI-DI
    06938396423001
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT, POST AQUABLATION THERAPY, THE PATIENT WENT SEPTIC. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR SEPSIS. THE PATIENT RECEIVED AN ABDOMINAL CT (COMPUTED TOMOGRAPHY) SCAN DUE TO THE INFECTION, AND A RECTAL INJURY WAS DETECTED. THE PATIENT THEN UNDERWENT SURGERY, AND AN ARTIFICIAL COLOSTOMY WAS APPLIED. THE PATIENT IS REPORTED TO BE DOING FINE. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WERE REPORTED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544307 APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM ULTRASONIC PULSED DOPPLER IMAGING SYSTEM IYN SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENT CO. LT 06938396423001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R