BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3073228 · Received April 23, 2013

    Report

    Report Number
    3005075853-2013-01926
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). INCORRECT CARTRIDGE SIZE THE ANALYSIS RESULTS SHOWED THAT ONE PSE60A DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND LOADED WITH A 45 MM RELOAD. THE RELOAD WAS NOTED TO BE UNFIRED. IT SHOULD BE NOTED THAT A 60MM DEVICE IS DESIGNED TO WORK ONLY WITH 60MM CARTRIDGES. IN ADDITION, THE BAILOUT DOOR WAS OUT OF POSITION AND THE LEVER WAS DOWN. PLEASE NOTE THAT IF THE MANUAL OVERRIDE DOOR IS REMOVED THE DEVICE IS DISABLED AND CANNOT BE USED FOR ANY SUBSEQUENCE FIRINGS UNTIL THE DOOR IS INSTALLED. FURTHERMORE, THE KNIFE WAS NOT FULLY RETRACTED, THUS THE DEVICE WOULD NOT OPEN. A TEST BAILOUT DOOR WAS PROPERLY INSTALLED; THE KNIFE WAS RETURNED TO HOME AND THEN, THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MISFIRED ON THE FIRST FIRING DURING A LEFT RENAL NEPHRECTOMY. THE SURGEON WENT TO THE BAIL OUT TO REMOVE DEVICE. THE DEVICE WOULD NOT OPEN. STEPS PROVIDED TO CONTINUE MANIPULATING THE OVER RIDE TO BRING KNIFE BLADE BACK. SURGEON CLIPPED THE DEVICE AND CUT ABOVE AND BELOW THE STAPLE LINE TO REMOVE THE DEVICE. PER THE CALLER, THE DEVICE WAS OPENED, BATTERY LOADED AND WHITE CARTRIDGE LOADED WITHOUT ISSUE. THE JAWS WERE OPENED AND PLACED ON THE RENAL ARTERY. ONCE THE SURGEON WENT TO FIRE THE DEVICE, IT MADE A NOISE AND THEN THERE WAS NO POWER. IT WAS AS IF THE BATTERY HAD DIED. THE SURGEON WENT DIRECTLY TO THE MANUAL OVERRIDE INSTEAD OF REVERSING THE KNIFE BLADE. THE MANUAL OVERRIDE DID NOT WORK. THE DEVICE COULD NOT BE OPENED. THE SURGEON THEN CLIPPED THE VESSEL ABOVE AND BELOW THE DEVICE IN ORDER TO REMOVE IT. THE DEVICE JAWS REMAIN IN THE CLOSED POSITION WITH TISSUE PRESENT. IT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174541 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4C52S

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR45W