BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIUI APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM

    MDR report key: 24142489 · Received January 22, 2026

    Report

    Report Number
    9615439-2025-00005
    Event Type
    Injury
    Date Received
    January 22, 2026
    Date of Event
    September 17, 2025
    Report Date
    October 4, 2025
    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

    MY COMPANY INTERNAL REVIEW REVEALED THAT BETWEEN JULY 2, 2025 AND JANUARY 19, 2026 (ET), THE PERSON RESPONSIBLE FOR ADVERSE EVENT REPORTING HAD SELECTED THE WRONG SUBMISSION ENTRY "TEST SUBMISSION" WHEN SUBMITTING MDR REPORTS (PACKAGED VIA ESUBMITTER) USING ESG NEXTGEN. IN CONSEQUENCE, A TOTAL OF 6 MDR REPORTS FAILED TO BE SENT TO THE PRODUCTION ENVIRONMENT BY FOLLOWING THE CORRECT ENTRY "NEW PRODUCTION SUBMISSION". THE FIRST DATE OF REPORT TO THE TEST ENVIRONMENT WAS OCTOBER 9, 2025. WE ARE NOW RESUBMITTING THIS MDR REPORT TO THE PRODUCTION ENVIRONMENT. THIS ISSUE WILL BE RESOLVED THROUGH THE QUALITY MANAGEMENT SYSTEM. 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.

    Additional Manufacturer Narrative · 0

    BASED ON THE ANALYSIS OF MEDICAL DEVICE REPORTING DATABASES IN REGIONS SUCH AS CHINA, AUSTRALIA AND CANADA, AS WELL AS CUSTOMER FEEDBACK DATA FROM MARKETS WHERE THE APOGEE 2300 AND ECBP-1 DEVICES HAVE BEEN RELEASED, IT CAN BE CONCLUDED THAT THERE WERE NO DESIGN DEFECTS IN THE APOGEE 2300 AND ECBP-1 DEVICES RESULTING IN SUCH INCIDENT; BASED ON THE REVIEW OF THE DHF OF THE MEDICAL DEVICES WITH THE SNS REPORTED IN THIS INCIDENT, IT CAN BE CONFIRMED THAT THE CORRESPONDING APOGEE 2300 AND ECBP-1 WERE IN COMPLIANCE WITH THE PRODUCT QUALITY REQUIREMENTS. FURTHERMORE, CLEAR SAFETY INSTRUCTIONS HAVE BEEN PROVIDED IN THE IFU (OPERATION MANUAL), FOR EXAMPLE: "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. " IT CAN BE DETERMINED THAT NON-COMPLIANT CLINICAL OPERATION MIGHT BE THE PRIMARY CAUSE OF THIS INCIDENT. WE WILL CONTINUE TO REMIND OPERATORS TO FOLLOW THE INSTRUCTIONS IN THE IFU (OPERATION MANUAL) WHEN OPERATING THE DEVICES, AND WE SHALL CONTINUE TO MONITOR THE SITUATIONS IN ACCORDANCE WITH THE REQUIREMENTS OF THE QUALITY MANAGEMENT SYSTEM.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BECAME AWARE THAT POST-AQUABLATION THERAPY, THE PATIENT PRESENTED WITH A FEVER IN POST-OP CARE AND WAS EXPERIENCING TACHYCARDIA. IT WAS DISCOVERED THAT THE PATIENT HAD AIR IN HIS ABDOMEN, AND THE PATIENT WAS THEN SENT FOR A COMPUTED TOMOGRAPHY (CT) IMAGING, REVEALING A RECTAL PERFORATION. ON (B)(6) 2025, A BOWEL DIVERSION PROCEDURE WAS PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. IT WAS REPORTED THAT NO ISSUES WERE EXPERIENCED DURING THE AQUABLATION THERAPY. STANDARD PROTOCOLS WERE FOLLOWED, AND ALL RECTAL INJURY PREVENTION PRECAUTIONS (PATIENT IN LITHOTOMY POSITION, BUTTOCKS 2 INCHES OFF THE END OF THE BED, DIGITAL RECTAL EXAM, 60CCS OF LUBRICANT DISPENSED IN THE RECTUM, 30CCS OF LUBRICANT PLACED ON TH RECTAL ULTRASOUND) WERE PERFORMED. FOLLOWING THE AQUABLATION THERAPY, THE TRUS PROBE WAS INSPECTED, AND NO BLOOD WAS VISUALIZED. FOLLOWING THE FOCAL BLADDER NECK CAUTERY PROTOCOLS, THE PATIENT'S RECTUM WAS INSPECTED BY THE PHYSICIAN FOR ANY INJURY. NO INJURY WAS FOUND UPON INSPECTION. 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
    203265 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