BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2082244 · Received May 9, 2011

    Report

    Report Number
    1527736-2011-00110
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ANVIL; JOINT COVER. THE ANALYSIS RESULTS FOUND THAT ONE EC60A DEVICE WAS RETURNED WITH THE ANVIL BENT UPWARDS AND WITHOUT CARTRIDGE RELOAD PRESENT. THE DAMAGE TO THE ANVIL IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER AN EXCESS OF TISSUE CAUSING THE ANVIL TO BENT AND FOR THE FIRING STROKE AND THE STAPLE FORM TO BE INCOMPLETE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS PRIOR TO SHIPMENTS, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT AND ARTICULATED POSITIONS WITH 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WERE MALFORMED STAPLES. THE INSTRUMENT COULD NOT BE CLOSED CORRECTLY, NO FURTHER INFORMATION IS AVAILABLE. 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
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK H4347J

    Patients

    Seq Age Sex Outcome Treatment
    1