BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIUI APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM

    MDR report key: 16441429 · Received February 26, 2023

    Report

    Report Number
    3012977056-2023-00023
    Event Type
    Death
    Date Received
    February 26, 2023
    Date of Event
    January 25, 2023
    Report Date
    June 12, 2023
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO. LT
    Product Code
    IYN
    UDI-DI
    06938396423001
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM (SN:116212190070R) AND ITS COMPONENT ECBP-1 ENDOCAVITY BIPLANE ULTRASOUND PROBE RELATED TO THE REPORTED EVENT WAS PERFORMED, WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCE, FAILURES, DISCREPANCIES OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING 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 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

    INVESTIGATION BY MANUFACTURER IS CURRENTLY IN-PROCESS. 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

    ON (B)(6) 2023, A (B)(6) MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT), THE US IMPORTER OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRANS-RECTAL ULTRASOUND PROBE (TRUS) PROBE, BECAME AWARE ON (B)(6) 2023 OF A POSSIBLE DEATH OF AN AQUABLATION PATIENT ON (B)(6) 2023, WITH DATE OF DEATH CONFIRMED VIA A DIRECT CONVERSATION ON (B)(6) 2023 WITH THE TREATING SURGEON. THROUGH A FOLLOW-UP CONVERSATION WITH THE TREATING SURGEON, PROCEPT CONFIRMED THE PATIENT'S DEATH WAS UNRELATED TO THE AQUABLATION PROCEDURE. THE TREATING SURGEON CONFIRMED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED. NO MALFUNCTION OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE WAS REPORTED TO PROCEPT. THE SURGEON NOTED THE PATIENT AS BEING STABLE. ALSO, THAT THE DISCHARGE OF THE PATIENT THE FOLLOWING DAY TO BE THE NORMAL COURSE OF ACTION. IN A FOLLOW-UP CONVERSATION, THE SURGEON SHARED THAT AN AUTOPSY WAS PERFORMED, AND A RECTAL PERFORATION WAS NOTED. THE SURGEON'S ASSESSMENT WAS THAT THE DEATH WAS DUE TO SEPSIS AND ASPIRATION DUE TO OBSERVED VOMITING. THE LOCATION OF THE PERFORATION WAS NOTED TO BE WELL BEYOND THE ANATOMICAL AREA WHERE THE WATERJET WAS USED, WHICH CONFIRMED THE TREATING SURGEON'S POSITION THAT THE DEATH WAS UNRELATED TO THE AQUABLATION TECHNOLOGY. THE PRIMARY CARE PHYSICIAN (PCP) OF THE PATIENT CONTACTED PROCEPT TO SHARE THE OUTCOME. IN THE CONVERSATION, THE PCP CONFIRMED THAT THE PATIENT HAD A HISTORY OF UROLOGICAL INFECTION AND DIVERTICULOSIS. THE PCP VERIFIED THAT THE PATIENT EXPIRED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382021 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 64 YR Male Death