BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 1930230 · Received December 16, 2010

    Report

    Report Number
    3005075853-2010-07204
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 8, 2010
    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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LONG60A DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH A CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED. A PARTIAL FIRE CAN OCCUR IF THE FIRING SEQUENCE IS INTERRUPTED, THE DEVICE IS OPENED, THEN CLOSED AND FIRING IS RESUMED, CAUSING THE INSTRUMENT TO LOCKOUT. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION USING A TEST CARTRIDGE RELOAD 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE DEVICE WAS CLOSED ON STOMACH THEN FIRED THROUGH FIRST STROKE. HOWEVER, IT BEGAN SLIPPING GEARS AND IT WOULD NOT FIRE THE REST OF THE RELOAD. THE SURGEON PUSHED THE RED BUTTON AND RELEASED FROM TISSUE. THE SURGEON REMOVED THE MALFORMED STAPLES AND PERISTRIP USING A MARILYN DISSECTOR. ANOTHER DEVICE AND RELOADS WERE USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. ONE DEVICE AND ONE RELOAD WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4U07L

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-ECR60G