BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC DISSECTOR

    MDR report key: 2980968 · Received February 4, 2013

    Report

    Report Number
    1717344-2013-00065
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC-ASSISTED HYSTERECTOMY, THE DEVICE TIP CAME INTO CONTACT WITH A METAL RING AND THE TIP DISENGAGED INTO THE PT CAVITY. THE PIECE WAS RETRIEVED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45838 ULTRASONIC DISSECTOR ULTRASONIC DISSECTION SYSTEM LFL COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ULTRASONIC REUSABLE GENERATOR - SERIAL # UNK| ULTRASONIC REUSABLE BATTERY PACK - SERIAL # UNK