BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM

    MDR report key: 2213958 · Received August 17, 2011

    Report

    Report Number
    3005075853-2011-03337
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 7, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE PAN.

    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 RIGHT HEMI COLECTOMY PROCEDURE, THE SURGEON FIRED THE STAPLER TWICE WITH NO ISSUE. THE FIRST FIRING WAS WITH A WHITE RELOAD, AND THE SECOND FIRING WAS WITH A BLUE RELOAD. AFTER THE SECOND FIRING, THE USED CARTRIDGE WAS DISCARDED AND THEY WERE UNABLE TO LOAD ANOTHER RELOAD. THE SURGEON SAID THAT THE JAWS WERE OPENED IN THE NORMAL WAY BUT IT LOOKED LIKE THE KNIFE BLADE WASN'T FULLY RETRACTED SO THE RELOAD WOULDN'T GO IN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1