BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STICTH POLYSORB 0 48 VIO DLU SU

    MDR report key: 2944196 · Received January 9, 2013

    Report

    Report Number
    1219930-2013-00020
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 12, 2012
    Manufacturer
    COVIDIEN, FORMERLY US
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HYSTERECTOMY. ACCORDING TO THE REPORTER: THE NEEDLE OF THE POLYSORB BROKE INSIDE THE PATIENT'S CAVITY DURING SURGICAL INTERVENTION. THE SURGEON WAS ABLE TO LOCATE AND REMOVE THE NEEDLE WITH A DIFFERENT INSTRUMENT. A NEW SULU WAS OPENED WITH THE SAME INSTRUMENT AND THE CASE WAS COMPLETED. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13074 ENDO STICTH POLYSORB 0 48 VIO DLU SU ENDOSTITCH KOG COVIDIEN, FORMERLY US B2C0574X

    Patients

    Seq Age Sex Outcome Treatment
    1