BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVI SCOUT

    MDR report key: 10851268 · Received November 17, 2020

    Report

    Report Number
    10851268
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 27, 2020
    Report Date
    October 30, 2020
    Manufacturer
    CIANNA MEDICAL, INC.
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SCOUT HAND PIECE DID NOT WORK WHEN CONNECTED TO MACHINE. PLUGGED IN DEMO HAND PIECE TO CHECK TO SEE IF IT WAS THE HAND PIECE OR MACHINE THAT DID NOT WORK, DEMO PIECE WORKED. OPENED NEW SCOUT HAND PIECE AND GAVE TO DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317878 SAVI SCOUT MARKER, RADIOGRAPHIC, IMPLANTABLE NEU CIANNA MEDICAL, INC. HPSU-01 H1808172

    Patients

    Seq Age Sex Outcome Treatment
    1 24090 DA