BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE ULTRASONIC DISSECTOR

    MDR report key: 3221655 · Received July 1, 2013

    Report

    Report Number
    1717344-2013-00480
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 25, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE#: (B)(4). DATE OF INITIAL REPORT: (B)(4) 2013. TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO 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 MYOMECTOMY, A PIECE OF THE ACTIVE WAVEGUIDE DISENGAGED FROM THE DISSECTOR AND FELL INTO THE PT CAVITY WHILE WORKING ON UTERINE TISSUE. THE PIECE WAS RETRIEVED BY THE SURGEON. THERE WAS NO REPORTED PT INJURY OR BLEEDING. THE SURGEON COMPLETED THE PROCEDURE USING A LIGASURE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298206 SINGLE ULTRASONIC DISSECTOR ULTRASONIC DISSECTOR LFL COVIDIEN LP 233449X

    Patients

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