BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENGO GIA ROTICULATOR 60-4.8 SULU

    MDR report key: 2974189 · Received February 12, 2013

    Report

    Report Number
    1219930-2013-00080
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 15, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    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: WEDGE RESECTION. ACCORDING TO THE REPORTER: BEFORE THE 2ND FIRING, WHEN THE SURGEON CLOSED THE DEVICE'S JAWS TEMPORARILY ON THE TISSUE, THE ROTATION COLLAR WAS SLIGHTLY SPLIT AND THE SURGEON HELD THE COLLAR WITH HAND AND FIRED THE DEVICE. AFTER FIRING, THE ROTATION COLLAR WAS SPLIT COMPLETELY IN TWO AND DISENGAGED FROM THE DEVICE. THE SURGEON CONFIRMED THE KNIFE CUT THE TISSUE BUT THE STAPLES WERE APPLIED BEFORE FORMED PROPERLY. THE TISSUE WAS SUTURED MANUALLY AND PROCEDURE WAS COMPLETED. BLEEDING WAS LESS THAN 200 CC. THERE WAS TISSUE DAMAGE AND UNANTICIPATED TISSUE LOSS. NO ILL EFFECT ON THE PT. NO REINFORCEMENT MATERIAL USED. THE SULU WAS DISCARDED AT THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62135 ENGO GIA ROTICULATOR 60-4.8 SULU DISPOSABLE STAPLER GDW COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability GIA UNIVERSAL, (B)(4), LOT #N2K0191X,| EXPIRATION DATE: 10/30/2017, MFR DATE: 10/2012.