BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 4260946 · Received November 19, 2014

    Report

    Report Number
    3005075853-2014-08032
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 16, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RECEIVED FOR ANALYSIS WITHOUT CARTRIDGE RELOAD. FURTHERMORE, THE DEVICE WAS FOUND TO HAVE THE CLAMPING MECHANISM DAMAGED. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE CLAMP ARM RELEASE AND RELEASE BUTTON WERE NOTED WORN AND DAMAGED IN THE AREA WHERE BOTH INTERACT. THIS DAMAGE IS CONSISTENT WITH WEAR THAT IS OBSERVED OVER MULTIPLE FIRINGS WHEN THE USER ACTUATES THE CLAMP RELEASE WITHOUT SQUEEZING THE CLOSING TRIGGER AGAINST THE HANDLE. WEAR IN THIS AREA CAN BE REDUCED BY SQUEEZING THE CLOSING TRIGGER AGAINST THE HANDLE, THEN DEPRESSING THE CLAMP RELEASE ON EITHER SIDE OF THE DEVICE. MAINTAIN PRESSURE ON THE CLAMP RELEASE AND SLOWLY ALLOW THE CLOSING TRIGGER TO OPEN. NO FURTHER FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. HOWEVER, A DRY FIRE WAS PERFORMED AND THE FIRING MECHANISM WORKED AS INTENDED. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE SURGEON HAD SUCCESSFULLY FIRED ONE BLUE LOAD ON THE APPENDIX, BUT AFTER RELOADING WITH A WHITE LOAD FOR MESOAPPENDIX, WAS UNABLE TO OPEN JAWS OF THE STAPLER. THE SURGICAL TECH WAS UNABLE TO OPEN THE JAWS AS WELL. THEY OPENED A SECOND DEVICE. WHILE OPENING THE NEW DEVICE, THE SCRUB TECH FINALLY WAS ABLE TO OPEN THE JAWS OF THE FIRST DEVICE. HE REMOVED THE LOAD AND PLACED IT IN THE SECOND GUN. WHEN ATTEMPTING TO FIRE, THE POWERED GUN CAME TO LIFE BUT THEN QUICKLY STOPPED. THE SURGEON THEN PASSED THAT DEVICE OUT OF THE FIELD AND REQUESTED AN ENDOLOOP AND SCISSORS TO FINISH THE MESOAPPENDIX LIGATION. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749650 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-ECR60B