BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM

    MDR report key: 21659829 · Received March 20, 2025

    Report

    Report Number
    3012977056-2025-00067
    Event Type
    Injury
    Date Received
    March 20, 2025
    Date of Event
    February 24, 2025
    Report Date
    March 20, 2025
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENT CO. LT
    Product Code
    IYN
    UDI-DI
    06938396423001
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, 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 SYSTEM IS A PURCHASED DEVICE HENCE MANUFACTURE DATE IS NOT AVAILABLE. 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. IT WAS REPORTED THAT NO INTERVENTION WAS TAKEN TO ADDRESS THE ISSUE. THE USER MANUAL OF THE APOGEE 2300 DEVICE LISTS DAMAGE TO THE RECTAL MUCOSA AS A POTENTIAL RISK OF THE PROCEDURE. BASED ON THE REVIEW OF TREATMENT LOG FILES, DHR, AND IFU, THE EVENT IS CONSIDERED NOT TO BE DEVICE RELATED.

    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 AFTER AQUABLATION THERAPY HAD BEEN COMPLETED. BLOOD WAS NOTED ON THE PROBE WHEN THE TREATING SURGEON REMOVED THE ECBP-1 TRUS PROBE. THE TREATING SURGEON PROCEEDED TO PERFORM A DIGITAL RECTAL EXAM AND OBSERVED BLOOD ON HIS GLOVE. A COLORECTAL SURGEON WAS BROUGHT IN AND IDENTIFIED A MUCOSAL TEAR IN THE RECTUM. THE MUCOSAL TEAR WAS SUTURED. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY. THE TREATING SURGEON REPORTED THAT NO RESISTANCE WAS MET WHEN THE ECBP-1 TRUS PROBE WAS INSERTED IN THE PATIENT AND DID NOT MENTION THAT THERE WAS ANYTHING UNUSUAL WITH THE PATIENT'S ANATOMY. 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
    334641 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 Required Intervention