BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 COMPACT ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM

    MDR report key: 2082254 · Received May 9, 2011

    Report

    Report Number
    3005075853-2011-01885
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE PAN. ONE SC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITIONS AND WITH A BLUE CARTRIDGE PRESENT. THE RELOAD WAS RECEIVED FULLY FIRED AND WITH THE PAN DISLODGED. THE PAN WAS REASSEMBLED TO THE CARTRIDGE, AND THE CARTRIDGE WAS LOADED INTO THE DEVICE AND UNLOADED WITHOUT ANY DIFFICULTIES. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT AND ARTICULATED POSITIONS WITH TEST CARTRIDGE RELOADS AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE PAN BECAME DISLODGED FROM THE CARTRIDGE, 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 OPEN RIGHT COLECTOMY PROCEDURE, THE DEVICE WAS FIRED WITHOUT ANY PROBLEM AT THE FIRST FIRING. WHEN THE NURSE WAS GOING TO REMOVE THE CARTRIDGE TO CHANGE IT, THE CARTRIDGE WAS DISASSEMBLED AND ONLY THE CARTRIDGE PAN WAS REMAINED IN THE JAW. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE NURSE COMMENTED THAT THE FORCE OF CHANGING THE CARTRIDGE WAS AS USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 COMPACT ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1