BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETS FLEX

    MDR report key: 1675708 · Received May 5, 2010

    Report

    Report Number
    3005075853-2010-02320
    Event Type
    Death
    Date Received
    May 5, 2010
    Report Date
    April 9, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN COLORECTAL PROCEDURE, THE SALES DIRECTOR WAS INFORMED BY A CONSULTANT SURGEON AT THE HOSPITAL THAT IS A COLLEAGUE OF A CONSULTANT COLORECTAL SURGEON, REPORTED DURING A MONTHLY INTERNAL AUDIT MEETING LA PATIENT DEATH. THE COLORECTAL SURGEON PRESENTED A COLORECTAL CASE, DURING THE PROCEDURE, THE DEVICE WAS FIRED WITHOUT A STAPLE CARTRIDGE. THE COLORECTAL SURGEON ALLEGED TO HAVE COMMENTED AT THE MEETING THAT THIS COULD HAVE BEEN A CONTRIBUTING FACTOR TO A SUBSEQUENT PATIENT DEATH. NO DEVICE WILL BE RETURNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED:

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death