BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC DISSECTOR QTY OF 6

    MDR report key: 3192409 · Received June 18, 2013

    Report

    Report Number
    1717344-2013-00438
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 18, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    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 GASTRIC BYPASS, THE SYSTEM ISSUED A RED ALERT AND A PIECE OF THE ACTIVE WAVEGUIDE DISENGAGED FROM THE DISSECTOR AND FELL INTO THE PATIENT CAVITY. THE PIECE WAS RETRIEVED FROM PATIENT CAVITY. THERE WAS NO PATIENT INJURY, BLOOD LOSS OR TISSUE DAMAGE REPORTED. THE SITE CONTACT WAS NOT ABLE TO PROVIDE ADDITIONAL DETAILS REGARDING THE DEVICE OR INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276083 ULTRASONIC DISSECTOR QTY OF 6 ULTRASONIC DISSECTOR LFL COVIDIEN LP 236457X

    Patients

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