BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 4101588 · Received September 19, 2014

    Report

    Report Number
    3005075853-2014-06523
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 31, 2014
    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
    EC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = CARTRIDGE. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: WHAT WAS MEANT BY THE STAPLES GOT OUT UNCONTROLLABLY? THE STAPLES FORMED A BALL. DID THE DEVICE DELIVER ANY STAPLES? YES IF YES, WERE THE STAPLES FORMED PROPERLY? NO. THEY FORMED A BALL. IF YES, WAS THE STAPLE LINE COMPLETE? NO. DID THE DEVICE CUT? THE DEVICE DID NOT CUT, EXPELLED AND PUSHED THE STAPLES WITHOUT CUTTING THE TISSUE IF YES, WAS THE CUT LINE COMPLETE? NOT APPLICABLE WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING OR OPENING)? NO WILL THE EC60A BE RETURNED? NOT YET. THE ANALYSIS RESULTS SHOWED THAT TWO ECR60D CARTRIDGE RELOADS WERE RECEIVED. THE RELOADS WERE RECEIVED FULLY FIRED AND WITH DAMAGE ON CARTRIDGE DECK. THE FOUND DAMAGE ON THE DECK IS CONSISTENT WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE; WHEN THIS HAPPENS THE KNIFE PLOWS THE STAPLES ON CARTRIDGE DECK AND SHAVING MAY OCCUR. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS OF THE RELOAD IT WAS DISASSEMBLED AND NO ANOMALIES WERE NOTED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOAD. NO FURTHER FUNCTIONAL TESTING COULD NOT BE CONFIRMED AS NO DEVICE WAS RETURNED FOR ANALYSISTHERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC SLEEVE PROCEDURE, THE DOCTOR USED A NEW EC60A DEVICE AND GREEN RELOADS AND GOLD RELOADS. THE FIRST SHOTS WITH GREEN RELOAD WERE DONE WITHOUT ANY PROBLEM, HOWEVER WHEN THE DOCTOR USED THE GOLD RELOAD, THE STAPLES GOT OUT UNCONTROLLABLY AND THE BLADE CAME OUT SKIDDING AND PUSHING THE STAPLES, WHICH ACCUMULATED FORMING A BALL THEREFORE THE DOCTOR OPENED ANOTHER GOLD, SHOWING THE SAME PROBLEM. THE DOCTOR PREFERS NOT USE THE GOLD RELOAD AND USE THE BLUE RELOAD. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585028 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4CR5K

    Patients

    Seq Age Sex Outcome Treatment
    1 EC60A