BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NTLC LINEAR CUTTER

    MDR report key: 3790015 · Received May 5, 2014

    Report

    Report Number
    3005075853-2014-03024
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    November 26, 2013
    Report Date
    December 4, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. DAMAGED STAPLE HEIGHT SELECTOR. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT TYPE OF PROCEDURE WAS THE DEVICE USED IN? CLOSURE OF COLOSTOMY. JUST FOR CLARIFICATION, DID THE DEVICE DID NOT FIRE (NO STAPLES DEPLOYED OR CUT LINE STARTED)? YES AND NO STAPLES DEPLOYED. WHAT IS THE CURRENT STATUS OF THE PATIENT? NORMAL. THE ANALYSIS RESULTS FOUND THAT THE NTLC75 INSTRUMENT WAS RECEIVED WITH A CARTRIDGE RELOAD LOADED IN THE INSTRUMENT. THE CARTRIDGE RELOAD HAD THE SWING TAB IN THE LOCKED POSITION, AND THE PROXIMAL TWO DRIVERS UP AND THE REMAINING DRIVERS WERE DOWN WITH STAPLES PRESENT. IT COULD NOT BE DETERMINED IF THE REPORTED INCIDENT WAS THE RESULT OF A PREMATURE LOCKOUT, OR THE RESULT OF AN INTERRUPTED FIRING STROKE. THE STAPLE SELECTOR WAS NOTED TO BE DAMAGED. NO FUNCTIONAL TEST WAS PERFORMED DUE TO CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE STAPLE HEIGHT SELECTOR DETACHED FROM ADJUSTING PLATE AND SUPPORT PLATE LOOSE. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE STAPLE HEIGHT SELECTOR BECAME DAMAGED, 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AS THE SURGEON WAS TRYING TO FIRE THE DEVICE, THE KNOB DIDN'T FORWARD. THE RELOAD WAS REPLACED AND AGAIN THE STAPLER DID NOT FIRE. THE KNOB WAS STUCK IN BOTH CASES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268473 NTLC LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4CJ5W

    Patients

    Seq Age Sex Outcome Treatment
    1