BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 1950192 · Received January 6, 2011

    Report

    Report Number
    3005075853-2011-00061
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    October 28, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE PAN. THE ANALYSIS RESULTS FOUND THAT ONE TR45W RELOAD WAS RETURNED INSTEAD OF ATS45. THE RELOAD WAS RECEIVED FULLY FIRED AND WITH THE PAN DISLODGED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE PAN TO DISLODGE. EVENT COULD NOT BE CONFIRMED AS NO DEVICE WAS RECEIVED FOR ANALYSIS. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS FIRED AND A STAPLE HAD LODGED IN THE DEVICE AND WAS UNABLE TO BE WASHED OUT. THE STAPLE AND CUT LINE WERE FINE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1