BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1162253 · Received September 16, 2008

    Report

    Report Number
    2032545-2008-05811
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    January 31, 2008
    Report Date
    August 19, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO SIGNIFICANT ANOMALIES. THE SUSPECTED ROOT CAUSE OF THE FAILURE WAS RELATED TO ATTACHMENT AND NOT CALIBRATION. THE DEVICE WAS RETURNED WITH THE CAPSULE SEPARATED FROM THE DELIVERY SYSTEM. THE CAPSULE TROCAR NEEDLE WAS ADVANCED AND SALIVA WAS PRESENT ON THE NEEDLE, IN THE TROCAR CAVITY, AND ON THE PROBOSCIS. THE PLUNGER HAD BEEN FULLY DEPRESSED AND WAS ONLY PARTIALLY RETRACTED. THERE WAS A BEND IN THE PULL WIRE AT THE HANDLE. EXTERNAL POWER WAS APPLIED FOR CALIBRATION VERIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT CALIBRATE AND WAS NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q187276

    Patients

    Seq Age Sex Outcome Treatment
    1