BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIUI APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM

    MDR report key: 13375753 · Received January 27, 2022

    Report

    Report Number
    9615439-2022-00001
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Report Date
    January 28, 2022
    Manufacturer
    SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO.,LT
    Product Code
    IYN
    PMA / PMN Number
    K173000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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

    PROCEPT BIOROBOTICS MARKETS THE ENDOCAVITY BIPLANE ULTRASOUND PROBE (PRODUCT NUMBER: ECBP-1) AND THE APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM FOR USE IN AQUABLATION THERAPY WITH PROCEPT BIOROBOTICS' AQUABEAM ROBOTIC SYSTEM. THE ECBP-1 ULTRASOUND PROBE IS MANUFACTURED BY SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. (SIUI). SECTIONS OF CHAPTER 5 - PROBE CLEANING AND DISINFECTION IN THE ECBP-1 ENGLISH OPERATION MANUAL (DOCUMENT NO.: SSCR9890000ENA)HAS COVERED VARIOUS CLEANING AND DISINFECTION PROCEDURES THAT ARE ACCEPTABLE TO /COMPATIBLE WITH THE PROBE. HOWEVER, FOR DIFFERENT COUNTRIES AND REGIONS, USERS NEED TO REFER TO LOCAL LAWS, REGULATIONS AND DIRECTIVES TO SELECT SUITABLE PROCEDURES, FOR THE US AREA, AS THE REQUIREMENT OF "VI. FDA'S SIX CRITERIA FOR REPROCESSING INSTRUCTIONS- B.SEMI-CRITICAL DEVICES" IN THE US FDA GUIDANCE "REPROCESSING MEDICAL DEVICES IN HEALTH CARE SETTINGS: VALIDATION METHODS AND LABELING" :" IF THE DEVICE DESIGN DOES NOT PERMIT STERILIZATION (E.G., DEVICE MATERIALS CANNOT WITHSTAND STERILIZATION), THEN HIGH LEVEL DISINFECTION SHOULD BE USED.". IF THE USER DOES NOT FOLLOW THE REQUIREMENT, THE USER OPERATION MAY FAIL TO COMPLY WITH FDA REGULATION. IN 5.1 OVERVIEW OF CHAPTER 5 PROBE CLEANING AND DISINFECTION OF ECBP-1_ENGLISH OPERATION MANUAL (DOCUMENT NO.: SSCR9890000ENA), IT IS REQUIRED THAT "THE DISINFECTION SHALL BE HIGH-LEVEL DISINFECTION (BY SEMI-IMMERSION OR FULL-IMMERSION). ACCORDING TO CUSTOMER FEEDBACK, IF THE END USER DOES NOT STRICTLY FOLLOW THE REQUIREMENTS IN THE OVERVIEW AND DOES NOT HANDLE THE PROBE REPROCESSING IN ACCORDANCE WITH LOCAL REGULATIONS, IT MAY RESULT IN THE RISK OF CROSS-INFECTION. SINCE THE ECBP-1 ULTRASOUND PROBE IS USED WITH THE AQUABEAM ROBOTIC SYSTEM,PROCEPT BIOROBOTICS AND SIUI ARE PROVIDING THE CUSTOMERS/USERS WITH PRODUCT NOTIFICATION TO PROVIDE REPROCESSING AND DISINFECTION INFORMATION TO REDUCE POTENTIAL RISKS TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1784959 SIUI APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM ULTRASONIC PULSED DOPPLER IMAGING SYSTEM IYN SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO.,LT APOGEE 2300

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown