BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELOAD FOR 60MM

    MDR report key: 2931606 · Received January 28, 2013

    Report

    Report Number
    3005075853-2013-00341
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 4, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY USING THE DEVICE, ON THE FIRST FIRING, USING A BLACK LOAD WITH GORE BUTTRESSING MATERIAL, FIRING ON THE PYLORUS THE FIRST STROKE OF THE DEVICE FELT TOUGH TO THE SURGEON. THE SECOND STROKE FELT ABNORMALLY TOUGH. THE THIRD STROKE REMAINED TOUGH AND WITH THE FOURTH STROKE TO BRING THE KNIFE BACK REMAINED TOUGH. THE RELEASE BUTTON WAS PUSHED AND THE DEVICE DID NOT OPEN. THE SURGEON PULLED THE HANDLE BACK AND THE DEVICE OPENED. THE THREE ROWS OF STAPLES ON THE PORTION OF THE STOMACH THAT WAS REMOVED FROM THE PATIENT HAD FORMED STAPLES. THE THREE ROWS OF STAPLES ON THE SLEEVE PORTION OF THE STOMACH WERE NOT FORMED. THE SURGEON OVER SEWED THE STAPLE LINE AND THERE WERE NO PATIENT CONSEQUENCES. THE SURGEON STATED THAT THE BUTTRESSING MATERIAL WAS NOT BUNCHED IN THE DEVICE. NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37983 RELOAD FOR 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1