BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING VAS/MED SULU

    MDR report key: 4931040 · Received July 22, 2015

    Report

    Report Number
    1219930-2015-00632
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    June 29, 2015
    Report Date
    July 1, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAG
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HEPATIC ABLATION (NEPHRECTOMY). ACCORDING TO THE REPORTER: THE SURGEON FIRED THE STAPLER, HEARD CRACK AND HAD NO MOVEMENT IN I BEAM/BLADE. THE SURGEON CONTINUED TO FIRE, BUT FELT THE STAPLER SOUNDED ODD. STAPLES FORMED PROPERLY ON THE PATIENT SIDE BUT DID NOT FORM ON KIDNEY SIDE. THE SURGEON HAD TO OPEN THE PATIENT TO FINISH THE CASE. THE SURGEON PACKED THE PATIENT WITH TOWELS AND SUTURED TO STOP THE BLEEDING. AS SUCH, THERE WAS UNANTICIPATED EXTENSION OF INCISION BY MORE THAN ONE INCH AND THERE WAS PATIENT INJURY OR HAZARD. THERE WAS UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. SURGERY TIME WAS EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS. NO DEVICE FRAGMENTS FELL INTO THE PATIENT. NO REINFORCEMENT MATERIAL WAS USED. THE CURRENT PATIENT STATUS IS THAT HE IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476513 EGIA 60 ARTICULATING VAS/MED SULU DISPOSABLE STAPLING DEVICE GAG COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA60AVM

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other