BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE

    MDR report key: 17343015 · Received July 18, 2023

    Report

    Report Number
    2124215-2023-37709
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 27, 2023
    Report Date
    August 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953003078
    PMA / PMN Number
    P000053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS ARTIFICIAL URINARY SPHINCTER PUMP UNDERWENT A THOROUGH ANALYSIS. THE PUMP WAS VISUALLY AND MICROSCOPICALLY EXAMINED, AND FUNCTIONALLY TESTED. NO ANOMALIES WERE FOUND WITH THE PUMP. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE REPORTED FOREIGN MATERIAL COULD NOT BE CONFIRMED. THEREFORE, A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING PREPARATION FOR AN ARTIFICIAL URINARY SPHINCTER (AUS) IMPLANT PROCEDURE, THE TECHNICIAN CHANGED GLOVES PRIOR TO HANDLING THE PUMP. ONCE, SHE STARTED PREPPING THE PUMP, WHITE DEBRIS WAS OBSERVED ALL OVER THE PUMP; TT IS UNKNOWN IF THE DEBRIS CAME FROM THE GLOVES OR IF IT WAS ON THE DEVICE BEFOREHAND. A NEW PUMP WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION FOR AN ARTIFICIAL URINARY SPHINCTER (AUS) IMPLANT PROCEDURE, THE TECHNICIAN CHANGED HER GLOVES PRIOR TO HANDLING THE PUMP. ONCE, SHE STARTED PREPPING THE PUMP, WHITE DEBRIS WERE OBSERVED ALL OVER THE PUMP. IT IS UNKNOWN IF THE DEBRIS CAME FROM HER GLOVES OR IF IT WAS ALREADY ON THE DEVICE. A NEW PUMP WAS OPENED FOR IMPLANTATION. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101118 AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72404127 1100286172 00878953003078

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male