BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIETTA 850

    MDR report key: 14254848 · Received April 29, 2022

    Report

    Report Number
    3018423337-2022-00003
    Event Type
    Injury
    Date Received
    April 29, 2022
    Report Date
    September 16, 2022
    Manufacturer
    FUJIFILM HEALTHCARE CORPORATION
    Product Code
    IYN
    UDI-DI
    04573596214046
    PMA / PMN Number
    K183456
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FUJIFILM HEALTHCARE CORPORATION IS PERFORMING ADDITIONAL INVESTIGATION TO DETERMINE THE ROOT CAUSE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED PENDING RESULTS OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 9, 2022, FUJIFILM HEALTHCARE CORPORATION CONCLUDED THE ROOT CAUSE INVESTIGATION ON THE ARIETTA 850. THE ERROR LOGS FROM THE DEVICE WERE ANALYZED. IT COULD NOT BE CONFIRMED THAT THERE WAS A CAUSAL RELATIONSHIP BETWEEN THE SCREEN BLACKING OUT AND THE PERFORATION. THE AVAILABLE INFORMATION WAS NOT ENOUGH TO ESTABLISH A ROOT CAUSE FOR THE PERFORATION. FUJIFILM WILL CONTINUE TO MONITOR ALL ARIETTA 850 SYSTEMS FOR SIMILAR ISSUES.

    Description of Event or Problem · 0

    ON (B)(6) 2022, FUJIFILM HEALTHCARE CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT DURING THE THERAPEUTIC CHOLEDOCHODUODENOSTOMY, THE SCREEN BLACKED OUT DURING THE DEPLOYMENT OF A BOSTON SCIENTIFIC AXIOS STENT AND A PATIENT SUSTAINED A BILIARY PERFORATION. A SURGERY WAS REQUIRED TO TREAT THE PERFORATION. THE PATIENT WAS STABLE POST PROCEDURE. THE EVENT DATE IS UNKNOWN. THERE IS NO DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437169 ARIETTA 850 ARIETTA 850 IYN FUJIFILM HEALTHCARE CORPORATION N/A N/A 04573596214046

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention