BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 4911495 · Received July 14, 2015

    Report

    Report Number
    3005075853-2015-04277
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 17, 2015
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # M53G1T. THE ANALYSIS RESULTS THAT ONE PLEE60A DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH AN GST60B CARTRIDGE RELOAD PRESENT. IN ADDITION A CARTRIDGE PAN WAS FOUND LODGED INSIDE THE CHANNEL. FURTHERMORE THE CARTRIDGE WAS RECEIVED BROKEN IN THREE PIECES. THE PAN WAS REMOVED FROM THE CHANNEL AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. ONE POSSIBLE CAUSE FOR THE CARTRIDGE DAMAGE COULD BE IMPROPER UNLOADING TECHNIQUE. PLEASE MAKE SURE THE DEVICE IS UNLOADED BY PUSHING THE CARTRIDGE UPWARD (TOWARD THE ANVIL) TO UNSNAP THE RELOAD FROM THE CARTRIDGE JAW. ANY TWISTING OR OFF CENTER PUSHING CAN LEAD TO THIS ISSUE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BYPASS PROCEDURE, THE DEVICE WOULD NOT OPEN AFTER THE FIRST USE, SO THE SURGEON PUSHED THE REVERSE BUTTON AND THEN PLACED A BLUE GST RELOAD IN THE DEVICE. AFTER THE SURGEON FIRED THE BLUE RELOAD AND THE DEVICE OPENED BACK UP, THE BLUE RELOAD BROKE IN HALF WHEN TAKING IT OUT OF THE DEVICE. THEY THEN TRIED TO LOAD A WHITE RELOAD IN THE DEVICE, BUT IT WOULD NOT FIT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457683 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK M9182P

    Patients

    Seq Age Sex Outcome Treatment
    1 GST60B & GST60W