BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 45 ARTICULATING MED/THICK SULU

    MDR report key: 3170124 · Received June 6, 2013

    Report

    Report Number
    1219930-2013-00432
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 16, 2013
    Manufacturer
    COVIDIEN, FORMERLY U.S. SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: GASTRIC TUBULAR (OPEN SURGERY, IT WAS NOT LAPAROSCOPIC BECAUSE THE PATIENT WAS DELICATE). ACCORDING TO THE REPORTER: CUSTOMER INFORMS THAT DURING THE LAST FIRING (HISS ANGLE), THE SULU COULD BE FIRED COMPLETELY BUT WHEN OPENING IT, IN ORDER TO REMOVE IT OUT OF THE PATIENT, THE BLADE REMAINED AT THE END OF THE SULU AND IT WAS IMPOSSIBLE TO OPEN IT NORMALLY. THE HANDLE SLID DOWN FROM THE SULU AND THE OPENING MECHANISM DID NOT WORK. IN ORDER TO REMOVE IT, THEY USED A HOOK AND MANUALLY THEY MADE TRACTION IN THE BLADE IN ORDER TO OPEN THE SULU. TWO DAYS AFTER THE SURGERY, THE PT HAD A FEVER AND HE WAS MADE A TEST USING CONTRAST MEDIUM AND SAW THE FISTULA. THEREFORE, THE PT HAD TO BE RE-OPERATED BECAUSE THE TENSION MADE IN THE TISSUE IN ORDER TO TRY TO OPEN THE SULU HAD CAUSED THAT FISTULA BETWEEN THE ESOPHAGUS AND THE HISS ANGLE. DURING THE PROCEDURE THEY TREATED THE FISTULA BY MANUAL SUTURING. AT PRESENT TIME THE PT IS STILL AT HOSPITAL. THERE WAS NO BLEEDING OF MORE THAN 250CC BUT THE FIRST SURGERY WAS DELAYED MORE THAN 30 MINUTES. NOTHING FELL IN THE PT CAVITY. THE SULU WAS USED WITH A EGIAUSTND. NO REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252001 EGIA 45 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY U.S. SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R EGIAUSTND| EGIA ULTRA UNIVERSAL STAPLER