BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 3243601 · Received July 23, 2013

    Report

    Report Number
    3005075853-2013-03691
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 21, 2013
    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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. CARTRIDGE PAN DISLODGED. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WERE THE JAWS DAMAGED? WAS THE DEVICE ABLE TO CLOSE? DID THE DEVICE HAVE TROUBLE OPENING? DID THE DEVICE CUT AS INTENDED? DID THE DEVICE STAPLE AS INTENDED? THE ANALYSIS RESULTS FOUND 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 IN THE ARTICULATED POSITION 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. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE PAN BECAME DISLODGED FROM THE RELOAD, IN ADDITION IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). 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 SEGMENT RESECTION LUNG (FOR BIOPT) PROCEDURE, THE ANVIL JAW DID NOT WORK PROPERLY. ANOTHER 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
    342656 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4CA8F

    Patients

    Seq Age Sex Outcome Treatment
    1