BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 3131052 · Received May 21, 2013

    Report

    Report Number
    1219930-2013-00383
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    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: THORACOTOMY. ACCORDING TO THE REPORTER: UPON USING THE THIRD CARTRIDGE, THE SURGEON FELT THE DEVICE WAS HARD TO OPERATE AND TRIED TO REMOVE THE DEVICE FROM THE CAVITY, THEN THE NEEDLE WAS BROKEN. NEW DEVICE WAS OPENED TO COMPLETE PROCEDURE. AFTER SURGERY, THE BROKEN NEEDLE WAS DETECTED BY X-RAY, BUT IT WAS SURROUNDED BY THE DIAPHRAGM AND COULD NOT BE RETRIEVED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS OR TISSUE DAMAGE. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225244 ENDO STITCH 10MM SUTURING DEVICE SURGICAL SUTURING DEVICE KOG COVIDIEN, FORMERLY US SURGICAL N2L0743X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EXPIRATION DATE 11/30/2017, (B)(4)| LOT #N0K0683, MANUFACTURE DATE 11/01/2012,| (B)(4), ENDO STITCH SOFSILK 0 48 BLACK DLU SU,