BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3830272 · Received May 23, 2014

    Report

    Report Number
    3005075853-2014-03523
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    March 6, 2014
    Report Date
    April 9, 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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: CARTRIDGE PAN DISLODGED. THE ANALYSIS RESULTS THAT ONE DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITHOUT A CARTRIDGE RELOAD PRESENT. IN ADDITION A CARTRIDGE PAN WAS FOUND LODGED INSIDE THE CHANNEL. 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. THE TEST CARTRIDGE WAS LOADED INTO THE DEVICE WITHOUT ANY DIFFICULTIES NOTED DURING THE FUNCTIONAL TESTING. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE PAN BECAME DISLODGED FROM THE RELOAD, IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE POWERED ECHELON WAS USED. AFTER THE THIRD RELOAD THE OR NURSE WAS UNABLE TO LOAD A NEW RELOAD. BOTH SURGEONS ATTEMPTED TO LOAD THE NEW RELOAD, BUT WITHOUT SUCCESS. A NEW POWERED ECHELON WAS OPENED. THE SAME RELOAD WAS LOAD WITHOUT ANY PROBLEM. SURGERY WAS PROLONGED TEN MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307666 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DV9L

    Patients

    Seq Age Sex Outcome Treatment
    1