BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVE CUTTER STAPLER

    MDR report key: 2991264 · Received March 6, 2013

    Report

    Report Number
    3005075853-2013-01081
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED CARTRIDGE ADDITIONAL INFORMATION PROVIDED: HOW MANY FIRINGS WERE USED TO COMPLETE THE TRANSACTION? FIRST FIRING. WHERE ANY STAPLES DEPLOYED IN THE TISSUE? ASKU. IF STAPLES WERE DEPLOYED, WERE THEY FORMED? YES. WAS THE CUT LINE COMPLETE? YES. WHERE THE CUT LINE AND STAPLE LINE EQUAL IN LENGTH? NO. WAS THE RETAINING PIN SET PROPERLY IN THE ANVIL HOLE? NO. DID THE TISSUE FIT EVENLY IN THE DEVICE? YES. HOW WAS THE FAILURE DETECTED (VISUALLY OR BY A LEAK TEST)? VISUAL. WAS THE DEVICE FIRED OVER AN EXISTING STAPLE LINE? ASKU. HOW WAS THE SMALL TEAR IN THE BOWEL RESOLVED? STAPLED. HOW WAS THE CASE COMPLETED? ROUTINE COMPLETION. WHAT IS THE CURRENT STATUS OF THE PATIENT? NO ADVERSE EFFECTS. THE ANALYSIS RESULTS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH ONE RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES, WITH THE WASHER UNCUT AND WITH THE DRIVERS AND KNIFE RECESSED BELOW THE CARTRIDGE DECK. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED RELOAD AND IT FIRED, FORMING ALL STAPLES AND CUTTING AS INTENDED. THE CUT LINE WAS COMPLETE, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE DEVICE LOCKOUT AND THE CARTRIDGE LOCKOUT WERE FUNCTIONAL, AND THE DEVICE FIRED WITHOUT ANY DIFFICULTIES. THERE WAS RESISTANCE FELT WHILE TRYING TO CLOSE THE DEVICE OR FORWARD THE PIN MANUALLY. HOWEVER THE DEVICE DID FIRE AS INTENDED. THE RELOAD WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS, AND THE CARTRIDGE CAP WAS NOTED TO BE DAMAGED. IT IS POSSIBLE THAT A HIGHER INTERACTION BETWEEN THE RETAINER PIN COUPLER AND THE CARTRIDGE CAP IS RESULTING IN THE INCREASE OF FORCE NEEDED TO MOVE THE PIN DISTALLY AND ULTIMATELY HIGHER FORCES ARE REQUIRED TO CLOSE THE DEVICE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CALLER THAT DURING A LAR PROCEDURE, THE DEVICE MISFIRED; ALL OF THE STAPLES DID NOT FIRE. THERE WAS A SMALL TEAR IN THE BOWEL. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96127 CURVE CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4C421

    Patients

    Seq Age Sex Outcome Treatment
    1