BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC DISSECTOR QTY OF 6

    MDR report key: 2962077 · Received January 22, 2013

    Report

    Report Number
    1717344-2013-00039
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THE ACTIVE WAVEGUIDE BROKE WHILE IN USE DURING A LAPAROSCOPIC HERNIA REPAIR AND FELL INTO THE PATIENT CAVITY. ALL PIECES WERE RETRIEVED FROM THE PATIENT CAVITY. THE DISENGAGEMENT OCCURRED TOWARDS THE MIDDLE OF THE PROCEDURE. ANOTHER ULTRASONIC SETUP WAS NOT NEEDED FOR THE REMAINDER OF THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE SITE CONTACT WAS NOT ABLE TO PROVIDE ADDITIONAL DETAILS REGARDING THE INCIDENT OR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31544 ULTRASONIC DISSECTOR QTY OF 6 ULTRASONIC DISSECTION SYSTEM LFL COVIDIEN LP 233790X

    Patients

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