BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRASONIC DISSECTOR QTY OF 6

    MDR report key: 2921757 · Received January 11, 2013

    Report

    Report Number
    1717344-2013-00019
    Event Type
    Death
    Date Received
    January 11, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 14, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE INDICATED THAT THE INCIDENT SAMPLE WAS DISCARDED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED, THE PATIENT UNDERWENT A LAPAROSCOPIC COLON PROCEDURE AND THEN EXPERIENCED A DETERIORATION IN HEALTH. A SECOND PROCEDURE WAS PERFORMED AND IT WAS OBSERVED THAT THE PATIENT HAD RECEIVED A BURN/PERFORATION TO THE BOWEL AND THAT THE PATIENT WAS NOT WELL. COVIDIEN WAS NOTIFIED ON (B)(6) 2013 THAT THE PATIENT PASSED AWAY SOMETIME AFTER THE SECOND PROCEDURE. THE INCIDENT DEVICE WAS DISCARDED AFTER THE FIRST PROCEDURE AND WILL NOT BE RETURNED FOR EVALUATION. THE SITE HAS NOT RELEASED ADDITIONAL INFORMATION REGARDING THE DEVICE, PATIENT OR INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18745 ULTRASONIC DISSECTOR QTY OF 6 ULTRASONIC DISSECTION SYSTEM LFL COVIDIEN LP UNK

    Patients

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