BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICISION

    MDR report key: 4131325 · Received September 17, 2014

    Report

    Report Number
    4131325
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    June 24, 2014
    Report Date
    September 17, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    SONICISION CORDLESS DISSECTOR NOT WORKING; NEW BATTERY WAS TRIED, PER REP BUT STILL DID NOT WORK. NEW HANDPIECE WAS OPENED TO THE FIELD AND SONICISION WORKED.MANUFACTURER RESPONSE FOR SONICISION CORDLESS DISSECTOR, SONICISION (PER SITE REPORTER).======================REP WAS NOTIFIED OF PROBLEM; REPORTED TO COMPANY AND SENT IN SHIP KIT. ANALYSIS FOUND THE BATTERY LEADS WERE BENT. THIS CAN HAPPEN DURING ASSEMBLY. REP TO RE-INSERVICE STAFF ON CORRECT ASSEMBLY PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575847 SONICISION INSTRUMENT, ULTRASONIC SURGICAL LFL COVIDIEN LP * 40830139X

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR