BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 3082893 · Received April 22, 2013

    Report

    Report Number
    1219930-2013-00310
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    January 23, 2013
    Report Date
    March 29, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LIVER RESECTION. ACCORDING TO THE REPORTER: DURING STAPLING OF SECOND RENAL ARTERY (THE FIRST ONE WAS ALREADY SUCCESSFULLY STAPLED), I FIRED THE STAPLER NORMALLY WITHOUT A PROBLEM. ALSO, THE CUTTING SEEMED TO OCCUR NORMALLY, BUT THEN IT DID NOT OPEN WHILE STILL ON THE ARTERY. WITH A HAND A PORT, I TRIED TO MANUALLY OPEN THE STAPLER, WHICH WAS IMPOSSIBLE. FINALLY, I USED A CLIP BELOW THE STAPLE LINE AND CUT OFF THE STAPLER AND ARTERY AT THE OTHER END. LUCKILY, THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500 CC, BUT WITH AN EXTENSIVE WARM ISCHEMIA TIME. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE WARM ISCHEMIA TIME TO THE DONOR WAS 9 MINUTES, TWICE THE AVERAGE TIME. THIS MAY HAVE IMPACT ON THE RESULTS OF THE TRANSPLANTATION. ALSO, THE DONOR SAFETY WAS AT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172994 EGIA ULTRA UNIVERSAL STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N2G0268UMX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other