BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 1905839 · Received November 23, 2010

    Report

    Report Number
    3005075853-2010-06664
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    September 10, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    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 WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL FOLLOWUP: DEVICE LISTED ON MEDWATCH AS AVAILABLE FOR EVALUATION. CONTACTED (B)(6) IN LEGAL DEPT WHO STATED THAT SHE SUBSEQUENTLY DETERMINED THERE WAS NO ISSUE WITH THE DEVICE AND THE ERROR WAS THE NURSE SO THE DEVICE WILL NOT BE RETURNING. (B)(6) STATED THAT THE STAFF HAD IN FACT BEEN IN-SERVICED AND SHOULD HAVE BEEN AWARE OF THIS DEVICE NOT BEING PRELOADED. THE NURSE WAS DISCIPLINED. THE PATIENT SUFFERED NO ADVERSE CONSEQUENCE - NO TRANSFUSION WAS REQUIRED. CONTACTED THE SALES REP WHO STATED HE HAD BEEN TOLD THIS 3RD HAND BUT HAD NOT RECEIVED SPECIFIC INFORMATION. HE WAS UNDER THE IMPRESSION THAT THE PATIENT HAD AN EXTENDED HOSPITAL STAY AS A PRECAUTION ONLY. - ATTACHMENT: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE ON THE FIRST, SECOND AND THIRD FIRING THE DEVICE FIRED MALFORMED STAPLES WHICH CREATED AN INADEQUATE STAPLE LINE. THE SURGEON STATED THAT THE DEVICE DID NOT FEEL SMOOTH WHEN SHE WAS FIRING THE DEVICE. THE MALFORMED STAPLES FELL INTO THE PATIENT BUT WERE RETRIEVED. CAUTERY WAS USED TO STOP THE BLEEDING ALONG THE STAPLE LINE AND THE CASE WAS COMPLETED. NO BLOOD TRANSFUSIONS WERE GIVEN. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization