BEUDAMED
    FDA Adverse Event Injury Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 2013177 · Received March 10, 2011

    Report

    Report Number
    3005075853-2011-00962
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    January 31, 2010
    Report Date
    February 10, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2011, (B)(6) 2011 AND (B)(6) 2011 AND TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN RIGHT COLECTOMY PROCEDURE, THE SURGEON SAID THE DEVICE LOCKS OUT EASILY AND REQUIRES ADDITIONAL FORCE AND HE DOES NOT FEEL THE STAPLES FORM ADEQUATELY FOR THE ANASTOMOSIS. IT IS NOT KNOWN IF HE USED SUTURE. HE STATED THE PATIENT MAY HAVE A LEAK. IT IS NOT KNOWN IF THE PATIENT HAS HAD AN ADDITIONAL PROCEDURE AT THIS TIME BUT THEY HAVE BEEN HELD AT THE HOSPITAL ADDITIONAL DAYS UNDER OBSERVATION. THE DEVICE WAS DISCARDED. THERE IS NO OTHER INFORMATION REGARDING THE PATIENT OUTCOME AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization CARTRIDGE = (B)(4)