BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIUI APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM

    MDR report key: 24784757 · Received April 4, 2026

    Report

    Report Number
    9615439-2026-00001
    Event Type
    Injury
    Date Received
    April 4, 2026
    Date of Event
    February 5, 2026
    Report Date
    March 31, 2026
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO.,LT
    Product Code
    IYN
    UDI-DI
    06938396423001
    PMA / PMN Number
    K173000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROCEPT BIOROBOTICS IS AN IMPORTER OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM. THE RECEIVING INSPECTION RECORD FOR THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM SERIAL NUMBER (B)(6) WAS REVIEWED. IT PASSED THE RECEIVING INSPECTION. NO REWORKS WERE PERFORMED BY PROCEPT BIOROBOTICS THAT WERE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE DEVICE MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE REVIEW OF THE OPERATION MANUAL FOR THE APOGEE 2300 DEVICE (IFU) FOUND THAT IT HAS COVERED THE RELATED SAFETY INSTRUCTION: 1.6 SAFETY L) WHEN PERFORMING THE RECTAL ULTRASOUND EXAM, BE GENTLE IN THE MOVEMENT. DO NOT PERFORM VIOLENT OPERATION, OTHERWISE IT MAY CAUSE RISKS OF PERFORATION OF THE RECTAL WALL, DAMAGE TO THE ANUS AND PERIANAL TISSUES, DAMAGE TO THE RECTAL MUCOSA OR BLEEDING. IN SUMMARY, THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE USER MANUAL OF THE APOGEE 2300 DEVICE LISTS RECTAL PERFORATION AS A POTENTIAL RISK OF THE PROCEDURE. BASED ON THE REVIEW OF TREATMENT LOG FILES, DHR, POST-MARKETING DATA AND IFU, THE EVENT IS CONSIDERED NOT TO BE DEVICE RELATED. THE INFORMATION RECEIVED DETERMINED THAT THE RECTAL PERFORATION WAS NOT RELATED TO THE SIUI APOGEE 2300 DEVICE. 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 AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, BLOOD WAS OBSERVED ON THE TIP OF THE TRUS PROBE UPON REMOVAL. IT WAS REPORTED THAT THE TREATING SURGEON INSERTED THE TRUS PROBE SLIGHTLY BELOW THE RECTUM, CAUSING A CUT IN THE PATIENT'S RECTUM. A STITCH WAS PLACED, AND THE PATIENT WAS ADMITTED OVERNIGHT, DISCHARGED THE NEXT DAY. 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
    100960 SIUI APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM ULTRASONIC PULSED DOPPLER IMAGING SYSTEM IYN SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO.,LT APOGEE 2300 06938396423001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention