BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM

    MDR report key: 22324791 · Received June 24, 2025

    Report

    Report Number
    3012977056-2025-00185
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    June 13, 2025
    Report Date
    July 1, 2025
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENT CO. LT
    Product Code
    IYN
    UDI-DI
    06938396423001
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, 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. CORRECTED DATA: THE UDI ((B)(4) INCLUDED IN THE INITIAL REPORT BELONGS TO SIUI ECBP-1 TRUS PROBE FOR ULTRASOUND. THE UDI FOR APOGEE 2300 ULTRASOUND SYSTEM IS (B)(4).

    Description of Event or Problem · 0

    A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE OF A RECTAL MUCOSAL TEAR WITH THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ITS ASSOCIATED ECBP-1 TRUS PROBE. THE TREATING SURGEON REPORTED THAT BLEEDING WAS NOTED AFTER ECBP-1 TRUS PROBE INSERTION. THE TREATING SURGEON DID A RECTAL EXAM POST ECBP-1 TRUS PROBE REMOVAL AND NOTED SMALL EXTERNAL MUCOSAL TEAR NEAR ANUS. THE TREATING SURGEON NOTED NO ISSUES WHEN DOING AN INTERNAL RECTAL FINGER SWEEP. NO ADDITIONAL INTERVENTIONS OR CARE WERE NEEDED. THE TREATING SURGEON IS UNSURE WHY THERE WAS A SMALL MUCOSAL TEAR, AS NO RESISTANCE WAS ENCOUNTERED WHEN ENTERING THE PATIENT (SUSPECTED IT COULD BE DUE TO THE PATIENT BEING OLDER AND HAVING FRAGILE SKIN). THE TREATING SURGEON WILL BE SEEING THE PATIENT IN 2 WEEKS FOR A FOLLOW-UP. 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
    1607782 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 Other