BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICISION

    MDR report key: 7625486 · Received June 21, 2018

    Report

    Report Number
    1717344-2018-00838
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Date of Event
    June 6, 2018
    Report Date
    June 21, 2018
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    LFL
    UDI-DI
    10884521052659
    PMA / PMN Number
    K101797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WORKED FINE IN THE BEGINNING BUT THEN THE INDICATOR LAMP TURNED RED. THE BATTERY WAS REPLACED, BUT THE STATUS WAS SAME. THE GENERATOR RAN IDLE AND UNABLE TO BE REMOVED FROM THE DISSECTOR. THE BLADE CAME OFF THE DISSECTOR, BUT THE REASON WAS UNKNOWN (BREAKAGE DUE TO SOME IMPACT OR ORIGINALLY CRACKED). PIECES OF THE DEVICE FELL INTO PATIENTS CAVITY BUT RETRIEVED. NEW DISSECTOR WAS CONNECTED TO NEW GENERATOR AND BATTERY, AND THE PROCEDURE WAS CONTINUED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466559 SONICISION INSTRUMENT, ULTRASONIC SURGICAL LFL COVIDIEN MFG DC BOULDER SCD391 80070145X 10884521052659

    Patients

    Seq Age Sex Outcome Treatment
    1