BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO DISSECT 5MM INSTRUMENT

    MDR report key: 3231589 · Received July 12, 2013

    Report

    Report Number
    2647580-2013-00384
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GET
    PMA / PMN Number
    K904578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC HYSTERECTOMY. ACCORDING TO THE REPORTER: WHILE LIGATING THE VAGINAL STUMP, THE DEVICE COULD NOT GRASP THE SUTURE, AND THE SURGEON FOUND ONE OF THE JAWS FELL INTO THE CAVITY. THE SURGEON RETRIEVED THE FALLEN JAW AND CONFIRMED NOTHING REMAINED IN THE CAVITY WITH X-RAY. THE DEVICE'S JAW WAS BROKEN AT THE BASE. NEW DEVICE WAS OPENED TO COMPLETE PROCEDURE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323025 ENDO DISSECT 5MM INSTRUMENT SINGLE USE LAPAROSCOPIC HAND INSTRUMENT GET COVIDIEN P2F0379X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other