BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA* TRI-STAPLE RR 60MM M/T RELOAD

    MDR report key: 6103189 · Received November 15, 2016

    Report

    Report Number
    1219930-2016-01194
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    October 26, 2016
    Report Date
    October 26, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    UDI-DI
    20884521191010
    PMA / PMN Number
    K102291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE RECEIVED FOR EVALUATION. DEVICE EVALUATION PENDING. NO FURTHER DETAILS REGARDING PATIENT, PRODUCT OR PROCEDURE WERE PROVIDED BY THE REPORTER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE SURGEON WAS PERFORMING A ROBOTIC SLEEVE GASTRECTOMY. THE FIRST STAPLE LOAD, FIRED AT THE ANTRUM OF THE STOMACH, DID NOT FIRE ALL THE WAY. THE SURGEON NOTED THAT THE STAPLE LINE WAS NOT CUT ALL THE WAY TO THE END. AFTER EXAMINING THE STAPLE LOAD, NON-CRIMPED STAPLES COULD STILL BE SEEN IN THE LOAD. THE STOMACH WAS NOT ABNORMALLY THICK AND THE STAPLER DID NOT SLOW DOWN DURING FIRING, AS TYPICALLY NOTED WITH EXTRA THICK TISSUE. THE SURGEON SAW AN EXPOSED/OPEN PORTION OF STOMACH. HE CONTINUED WITH THE OTHER RELOADS WITH NO OTHER ISSUES NOTED. THE SURGEON SUTURED AND OVERSEWED THE ANTRUM OF THE STOMACH TO CORRECT THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754060 ENDO GIA* TRI-STAPLE RR 60MM M/T RELOAD STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIATRS60AMT N6J0539KX 20884521191010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN IDRIVE ULTRA HANDLE AND EGIA ADAPTER