BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON LINEAR CUTTER RELOAD

    MDR report key: 3911295 · Received July 2, 2014

    Report

    Report Number
    3005075853-2014-04626
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHERE WAS THE LEAK? DO THEY ROUTINELY OVERSEW? BMI? GENDER OF PATIENT? WAS BUTTRESSING MATERIAL USED? WHAT CARTRIDGE WAS USED BEFORE THE BLEEDING? CURRENT STATUS OF PATIENT? AS REPORTED, SURGEON EXPERIENCED A MISFIRE WITH THE GREEN RELOAD. THE PATIENT REMAINED HOSPITALIZED 6 DAYS LONGER THAN HER TYPICAL PATIENTS DUE TO A LEAK. WHEN THE PATIENT HAD HER FIRST FOLLOW-UP VISIT IN THE OFFICE IT WAS DETERMINED THAT SHE NEEDED TO BE RE-ADMITTED. IT WAS NOTED THAT THE PATIENT HAD AN ULCERATION AT THE SITE OF THE MISFIRE. SURGEON MENTIONED THAT THE PATIENT HAS HAD ENOUGH BLOOD TRANSFUSIONS TO REPLACE HER ENTIRE BODY BLOOD VOLUME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC SLEEVE PROCEDURE, ON THE SECOND FIRING WITH A GREEN CARTRIDGE THE REMNANT SIDE OF THE STAPLE LINE WAS FORMED AND INTACT. THE PATIENT SIDE HAD ONLY ONE STAPLE LINE FORMED AND THE OTHER TWO STAPLE LINES WERE NOT. THERE WAS SIGNIFICANT BLEEDING ON THE STOMACH. THE SURGEON OVER SEWED IT TO CONTROL THE BLEEDING. THE PATIENT DEVELOPED A LEAK POST-OP. AS A RESULT THE PATIENT REMAINED IN THE HOSPITAL SIX DAYS LONGER THAN ANTICIPATED. THERE WAS NO ISSUE WITH FIRING THE DEVICE. THE SURGEON WAITED THE 15 SECONDS PRIOR TO FIRING. THEY CLEANED/SWISHED THE JAWS OF THE DEVICE BEFORE LOADING A NEW CARTRIDGE INTO THE JAWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385669 ECHELON LINEAR CUTTER RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DEVICE - PLE60A