BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 3231878 · Received July 10, 2013

    Report

    Report Number
    1219930-2013-00529
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 10, 2013
    Report Date
    July 3, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER: (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: VATS. ACCORDING TO THE REPORTER: A "BROKEN" SOUND WAS HEARD DURING THE SECOND SQUEEZING ACTION ON THE LOOP HANDLE. NO STAPLES COULD FORM THEN AND THE KNIFE BLADE WAS NOT ABLE TO GO FORWARD. HE COULD NOT SQUEEZE THE HANDLE ANYMORE. SO HE RETRACTED THE KNIFE BLADE AND OPENED A NEW SET OF EGIAUSTND AND EGIA60AXT TO PROCEED WITH THE FIRING. HOWEVER, SAME TISSUE WAS FOUND ON THE SECOND SQUEEZING ACTION ON THE LOOP HANDLE. HE THEN USED ANOTHER NEW SET OF EGIAUSTND AND EGIA45AXT TO COMPLETE THE SURGERY. NO REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE. THERE WAS UNANTICIPATED TISSUE LOSS. MORE LUNG TISSUE USED (INCLUDING THE DAMAGED TISSUE) IN ORDER TO GET A COMPLETE STAPLE LINE FORMATION. ALL THE DAMAGED TISSUE WAS REMOVED EVENTUALLY. TO REMEDY THE MALFORMATION OF STAPLES, ANOTHER LOADING WAS FIRED OVER THE PREVIOUS MALFORMED STAPLE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317038 EGIA 60 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N3C0471LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PMA/510(K) K083519| LOT # N3B0162UMX, MFR 03/2013, EXP 03/31/2018,| EGIA ULTRA UNIVERSAL STAPLER, CAT # EGIAUSTND,