BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 2822065 · Received October 9, 2012

    Report

    Report Number
    1219930-2012-00832
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Date of Event
    July 3, 2012
    Report Date
    July 9, 2012
    Manufacturer
    COVIDIEN, FORMERLY US
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 BROKE DURING TOGGLE. THE DOCTOR USED ANOTHER DEVICE AND WAS ABLE TO CONTINUE THE CASE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH 10MM SUTURING DEVICE SUTURING DEVICE KOG COVIDIEN, FORMERLY US

    Patients

    Seq Age Sex Outcome Treatment
    1