BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ILS 21MM, CURVED

    MDR report key: 3013550 · Received March 20, 2013

    Report

    Report Number
    3005075853-2013-01329
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION PROVIDED: HOW WAS IT CONFIRMED THAT THE ANVIL WAS SECURED TO THE TROCAR? CLICK WAS HEARD. WHAT CONFIRMATION WAS RECEIVED INDICATING THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? CRUNCH HEARD. WAS MORE THAN ONE FIRING STROKE REQUIRED TO HEAR THE CRUNCH? NO. WHERE WITHIN THE GREEN TISSUE COMPRESSION/GAP SETTING SCALE WAS THE ORANGE INDICATOR SET FOR FIRING? ASKU. DID THE RED SAFETY REMAIN ENGAGED UNTIL FIRING? ASKU. TYPE OF TISSUE? FRIABLE. WAS THE BREAKAWAY WASHER COMPLETELY CUT THROUGH? THEY DO NOT TYPICALLY INSPECT THE WASHER FOR THIS TYPE OF PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUX-N-Y, WHEN PERFORMING THE GASTROJEJUNOSTOMY, THE DEVICE DID NOT FORM THE ANASTOMOSIS CORRECTLY. HALF OF THE ANASTOMOSIS WAS STAPLED AND THE OTHER HALF APPEARED TO NOT BE STAPLED. THE STAPLES THAT WERE DEPLOYED WERE FORMED. THE CASE WAS COMPLETED BY SEWING THE ANASTOMOSIS WITH 2-0 SILK. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115857 ENDO ILS 21MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4AW9K

    Patients

    Seq Age Sex Outcome Treatment
    1