BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ILS, 29MM, CURVED

    MDR report key: 2822407 · Received November 7, 2012

    Report

    Report Number
    3005075853-2012-05049
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    May 8, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. PER THE SALES REP, 'WHERE ANY ISSUES IDENTIFIED WITH EITHER DEVICE DURING THE INITIAL PROCEDURE? NO. WHAT WERE THE PATIENTS PREEXISTING CONDITIONS? DIVERTICULITIS AND CANCER. HOW LONG POST OP WAS THE FISTULA IDENTIFIED? DO NOT REMEMBER BUT MORE THAN A FEW DAYS. WAS THE FISTULA ALONG THE STAPLE LINE OR NEAR THE STAPLE LINE? DO NOT KNOW WHICH STAPLE. LINE? DISTAL RESECTION. WAS THE PATIENT RETURNED TO THE OR? YES. WAS THERE A LEAK TEST INTRA-OP? YES HOW WAS IT PERFORMED? EGD SCOPE AND AIR. HOW IS THE PATIENT CURRENTLY? STABLE RECOVERED. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? YES. WAS THE ILEOSTOMY PART OF THE PLANNED INITIAL PROCEDURE? YES. PLEASE OUTLINE THE TIMELINE AND WHEN/HOW EVERYTHING WAS IDENTIFIED? SURGERY, PATIENT RETURNED TO OR POST OP DAY (?). WHO FIRED THE DEVICES AND WHAT IS THEIR LEVEL OF EXPERIENCE? SURGEON, HIGH. DOES THE SURGEON BELIEVE THAT THE FISTULA IS CAUSED BY THE DEVICE? NO WHICH DEVICE CONTOUR/EC45A - SHE'S NOT SURE, FISTULA CAUSED BY LEAK ETC? WAS THE FISTULA ALONG THE STAPLE LINE OR NEAR THE STAPLE LINE? ONE OF THE TWO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC LAP LOW ANTERIOR RESECTION WITH DIVERTING LOOP ILEOSTOMY PROCEDURE, THERE WAS A POST OP FISTULA: NEAR THE DISTAL STAPLE LINE NEXT TO THE ANASTAMOSIS. A LINEAR CUTTER WAS USED FOR TRANSECTIONS WITH CIRCULAR FOR ANASTAMOSIS. THE LEAK WAS REPAIRED WITH SUTURE. THERE WERE NO OTHER PATIENT CONSEQUENCES. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO ILS, 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention