BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 3222087 · Received July 1, 2013

    Report

    Report Number
    1219930-2013-00502
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 11, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    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: AFTER STITCHES WERE PLACED WITH THE ENDOSTITCH DEVICE, AND AFTER THE DEVICE WAS REMOVED FROM THE PATIENT THROUGH THE TROCAR, THE ENDOSTITCH NEEDLE BROKEN IN HALF. THE ENDOSTITCH PORTION OF THE CASE WAS COMPLETE AND CLINICALLY SUCCESSFUL, NO NEW DEVICE WAS REQUIRED. NEEDLE WAS NOT BROKEN INTRACORPOREALLY. NO PIECES REMAINED IN PATIENT. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298269 ENDO STITCH 10MM SUTURING DEVICE DISPOSABLE SUTURING DEVICE KOG COVIDIEN, FORMERLY US SUR

    Patients

    Seq Age Sex Outcome Treatment
    1