BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2142458 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02640
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH THE TIP OF THE ANCILLARY TROCAR LODGED INSIDE THE ANVIL. THE BREAKAWAY WASHER WAS PRESENT AND UNCUT AND THE DEVICE WAS RECEIVED FULLY LOADED WITH STAPLES. THE DEVICE WAS TESTED FOR FUNCTIONALITY USING A TEST ANVIL AND THE DEVICE WAS FIRED AT THE HIGH-B SETTING; IT FIRED AND FORMED ALL THE STAPLES, AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. IT COULD NOT BE ASCERTAINED AS TO HOW THE DAMAGE TO THE ANCILLARY TROCAR OCCURRED. IT SHOULD BE NOTED THAT IF TORQUE OR EXCESS FORCE IS APPLIED TO THE ANCILLARY TROCAR, IT MAY CAUSE THE TROCAR TO BREAK. IT SHOULD BE NOTED THAT TO DETACH THE ANCILLARY TROCAR, IT SHOULD BE ROTATED 45 DEGREES IN THE ANVIL SHAFT SO THAT THE FINGER NOTCHES ARE PERPENDICULAR TO THE LOCKING SPRINGS (UNLOCKED POSITION). UTILIZING THE FINGER NOTCHES, PULL THE ANCILLARY TROCAR OUT OF THE ANVIL SHAFT. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN SIGMOID PROCEDURE, THE TROCAR WENT ABOVE THE LINE OF STAPLES. HOWEVER, THE ANVIL COULD NOT BE ATTACHED TO THE DEVICE. THE DEVICE COULD NOT BE FIRED. AS A RESULT, THE PATIENT RECEIVED A COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4RR5A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention