BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VLOC 180 ESTITCH ABS 0 8 LOOP

    MDR report key: 3961403 · Received May 29, 2014

    Report

    Report Number
    1219930-2014-00413
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: TOTAL LAP HYSTERECTOMY. ACCORDING TO THE REPORTER: WHILE TAKING THE FIRST BITE WITH THE NEEDLE, THE NEEDLE BROKE IN HALF. THE HALF OF NEEDLE THAT BROKE OFF LODGED IN THE VAGINAL CUFF AND WAS EASILY ABLE TO BE RETRIEVED. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES. A DEVICE FRAGMENT FELL INTO THE PATIENT BUT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315954 VLOC 180 ESTITCH ABS 0 8 LOOP DISPOSABLE SUTURING DEVICE KOG COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N4B1003X

    Patients

    Seq Age Sex Outcome Treatment
    1