BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIUI APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM

    MDR report key: 15263473 · Received August 20, 2022

    Report

    Report Number
    3012977056-2022-00106
    Event Type
    Injury
    Date Received
    August 20, 2022
    Date of Event
    July 15, 2022
    Report Date
    November 14, 2022
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO. LT
    Product Code
    IYN
    UDI-DI
    06938396423001
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE OF REPORTED EVENT HAS NOT YET BEEN ESTABLISHED. INVESTIGATION IS CURRENTLY INPROCESS.

    Additional Manufacturer Narrative · 0

    H.10 ADDITIONAL MANUFACTURER NARRATIVE: FOR CORRECTED DATA REFER TO SECTION B.5 - DESCRIBE EVENT OR PROBLEM. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM (SN:(B)(6)) 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 PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). ON (B)(6) 2022, PROCEPT BIOROBOTICS CORPORATION (PROCEPT), THE US IMPORTER OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE, BECAME AWARE THAT POST-AQUABLATION PROCEDURE THE PATIENT HAD A RECTAL PERFORATION. THE TREATING PHYSICIAN REPORTED THAT THE RECTAL PERFORATION OCCURRED WITH THE ECBP-1 TRUS PROBE. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION DESPITE THE REPORTED EVENT. NO MALFUNCTION OF THE ECBP-1 TRUS PROBE WAS REPORTED TO PROCEPT. PROCEPT HAS REQUESTED ADDITIONAL INFORMATION REGARDING ACTION TAKEN TO ADDRESS THE RECTAL PERFORATION.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). ON 22-JUL-2022, PROCEPT BIOROBOTICS CORPORATION (PROCEPT), THE US IMPORTER OF THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM AND ASSOCIATED COMPONENT ECBP-1 TRUS PROBE, BECAME AWARE THAT POST-AQUABLATION PROCEDURE THE PATIENT HAD A RECTAL PERFORATION. THE TREATING PHYSICIAN REPORTED THAT THE RECTAL PERFORATION OCCURRED WITH THE ECBP-1 TRUS PROBE. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION DESPITE THE REPORTED EVENT. NO MALFUNCTION OF THE ECBP-1 TRUS PROBE WAS REPORTED TO PROCEPT. PROCEPT HAS REQUESTED ADDITIONAL INFORMATION REGARDING ACTION TAKEN TO ADDRESS THE RECTAL PERFORATION. ADDITIONAL INFORMATION OBTAINED BY PROCEPT THROUGH THE TREATING SURGEON CONFIRMED THAT THE PATIENT WAS PLACED WITH A TEMPORARY COLOSTOMY BAG TO ALLOW FOR HEALING OF THE RECTAL PERFORAITON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301873 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 Male Other