BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS 29MM CURVED

    MDR report key: 4013017 · Received August 15, 2014

    Report

    Report Number
    3005075853-2014-05737
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 7, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF FURTHER DETAILS ARE RECEIVED AND/OR DEVICE IS RECEIVED AND ANALYZED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RECTOSIGMOIDECTOMY PROCEDURE, WHEN REMOVING THE STAPLER OUT OF THE PATIENT THE WARHEAD DID NOT COME OUT, IT WAS STUCK TO THE STAPLES. IT WAS NECESSARY TO REDO THE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490001 ILS 29MM CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4C47Y

    Patients

    Seq Age Sex Outcome Treatment
    1