BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICISION

    MDR report key: 20694277 · Received November 15, 2024

    Report

    Report Number
    20694277
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    July 25, 2024
    Report Date
    September 13, 2024
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    AFTER INSTALLING THE BATTERY, THE DEVICE WAS BLINKING BLUE AND RED LIGHTS AND MADE A NOISE ONCE YOU PRESSED ON THE TRIGGER TO ACTIVATE. NO PATIENT HARM. PROCEDURE COMPLETE WITH A DIFFERENT DEVICE. MANUFACTURER RESPONSE FOR CORDLESS ULTRASONIC DISSECTION SYSTEM, COVIDIEN SALES LLC- ENDO (PER SITE REPORTER). REP REPORTED ISSUE INTERNALLY, ADVISED TO DISPOSE DEFECTIVE PRODUCT AS IT'S NO LONGER COMPATIBLE WITH CURRENT GENERATORS, AND A REPLACEMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306656 SONICISION INSTRUMENT, ULTRASONIC SURGICAL LFL COVIDIEN LP SCDA39 32770259X

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female