BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 4170059 · Received October 14, 2014

    Report

    Report Number
    2647580-2014-00863
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 18, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP COLON. ACCORDING TO THE REPORTER: UPON ANASTOMOSIS OF COLON WITH ENDO GIA STAPLES, FLEXIBLE SIGMOIDOSTOMY REVEALED A LEAK. THE SURGEON USED ANOTHER ENDOSCOPIC STAPLER AND THE LEAK PERSISTED. THE LAP CASE NEEDED TO BE CONVERTED TO OPEN AND THE LEAK WAS REPAIRED USING A TA STAPLER. NO REINFORCEMENT. TISSUE WAS NORMAL THICKNESS; NON-INFLAMED RECTUM. PATIENT WAS DISCHARGED LAST WEEK AND IS DOING WELL. THE SURGEON CLAIMS THAT CASE WAS UNCOMPLICATED; THE ONLY REASON FOR OPENING WAS LACK OF CONFIDENCE IN THE ENDO GIA. THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS UNANTICIPATED TISSUE DAMAGE. THERE WAS A DELAY OVER 30 MINUTES BECAUSE CASE CONVERTED TO OPEN. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 250CC. ADDITIONAL INFORMATION: WAS THERE POOR STAPLE FORMATION: SHE SAID THE STAPLE FORMATION LOOKED GOOD BUT THAT IT OPENED UP LIKE A ZIPPER IN THE MIDDLE. SO, THE STAPLES WERE FORMED, BUT THE STAPLE LINE OPENED UP IN THE MIDDLE. WAS THE STAPLE LINE COMPLETE: YES. SHE BELIEVES IT WAS. WAS THE SAME STAPLER EGIAUSTND (LOT: P4D0814X) USED WITH ALL OF THE RELOADS RELATED TO THIS CASE: YES. IF NO, WHAT IS THE PRODUCT ID AND LOT NUMBER FOR THE HANDLE USED WITH EACH RELOAD. IF THE CUSTOMER CANNOT REPORT THE PRODUCT ID AND LOT NUMBER, WAS IT A LEGACY UNIVERSAL (SUCH AS 030403, 030449, EGIAUNIVXL), OR WAS IT AN EGIA ULTRA (SUCH AS EGIAUSHORT, EGIAUSTND, EGIAUXL). WILL THE DEVICE BE RETURNED FOR INVESTIGATION AS REPORTED: AS I EXPRESSED IN THE E-MAIL THE FACILITY IS HAVING DISCUSSIONS IF THEY WOULD LIKE TO RETURN THIS FOR OUR REVIEW. I WILL LET YOU KNOW WHEN THEY GET BACK TO ME. DESCRIBE THE TISSUE DAMAGE AND PROVIDE DETAILS ON HOW THE DAMAGE WAS TREATED/CORRECTED: THE TISSUE DAMAGE OCCURRED WHEN A LAP PROCEDURE WAS TAKEN TO OPEN A. WAS THE DAMAGE IRREVERSIBLE: YES, YOU CAN'T UNDO AN OPEN PROCEDURE THAT SHOULD HAVE BEEN DONE LAP 7. WAS ANY ADVERSE EVENT REPORTED AS A RESULT OF ANY DELAY IN SURGERY: (I.E. AN EXTENSION OF THE HOSPITAL STAY, INFECTION, ETC.) RESPONSE FROM A NURSE: AS DR. (B)(6) MENTIONED EARLIER, THE SURGERY TIME WAS EXTENDED DUE TO THE NEED TO GO OPEN. I DON'T UNDERSTAND WHAT YOU MEAN BY ADVERSE EVENT BEING REPORTED. DO YOU MEAN TO THE STATE: OR JUST THROUGH THE HOSPITAL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651358 EGIA ULTRA UNIVERSAL STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC EGIAUSTND P4D0814X

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R| S EGIA60AMT, EGIA 60 ARTICULATING MED/THICK SULU,