BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29MM

    MDR report key: 1392391 · Received May 21, 2009

    Report

    Report Number
    3005075853-2009-02976
    Event Type
    Injury
    Date Received
    May 21, 2009
    Date of Event
    April 17, 2009
    Report Date
    April 28, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    FHM
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON, "I DID A LAPAROSCOPIC SIGMOID COLECTOMY ON FRIDAY. I USED A LAPAROSCOPIC GIA TO DIVIDE THE BOWEL DISTALLY, USING ONE RELOAD. I THEN USED AN EEA TO PERFORM THE ANASTOMOSIS. THE STAPLER SEEMED TO FUNCTION APPROPRIATELY, AND I TESTED THE ANASTOMOSIS WITH AIR INSUFFLATION AT THE COMPLETION OF THE CASE. THE ANASTOMOSIS SUBSEQUENTLY LEAKED, AND AT REEXPLORATION, THE ANTERIOR STAPLE LINE WAS DISRUPTED. IN THE COURSE OF TAKING DOWN THE ANASTOMOSIS AT THE SECOND OPERATION, SOME OF THE STAPLES APPEARED TO BE INCOMPLETELY CLOSED. WE SAVED SOME OF THEM TO SHOW YOU. THERE WERE CLEARLY CONSEQUENCES, AS THE PATIENT IS STILL CRITICALLY ILL IN THE ICU WITH SEPSIS, EVEN AFTER REPEAT OPERATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29MM FHM ETHICON ENDO-SURGERY, LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention