BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 2770614 · Received October 3, 2012

    Report

    Report Number
    3005075853-2012-04514
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: WAS THERE ANY DIFFICULTY WITH THE DEVICE DURING THE INITIAL PROCEDURE? NO. WAS THE IMA SKELETONIZED PRIOR TO FIRING? YES. WHAT DID THE STAPLE LINE LOOK LIKE? LOOKED FINE. WAS THERE ANY BLEEDING NOTICED AFTER THE FIRST TRANSECTION IN THE INITIAL OPERATION? IF SO, WHAT WAS PERFORMED TO CONTROL THE BLEEDING? NO. HOW IS THE PATIENT CURRENTLY? FINE. PATIENTS PREEXISTING CONDITIONS? NONE. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? YES. PATIENTS AGE, SEX AND WEIGHT? DON'T KNOW. WAS THE DEVICE DISCARDED? YES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN OPEN COLECTOMY PROCEDURE, THE PATIENT WAS BROUGHT BACK TO SURGERY FOR BLEEDING. IT WAS FOUND THAT THERE WAS BLEEDING ON THE STAPLE LINE FIRED OVER THE INFERIOR MESENTERIC ARTERY (IMA). THE BLEEDING WAS CONTROLLED DURING THE SECOND PROCEDURE AND THE PATIENT IS REPORTED TO BE STABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ECR60W