BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 1984152 · Received February 10, 2011

    Report

    Report Number
    1527736-2011-00042
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 23, 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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE SURGEON STATES THAT UPON FIRING (FOUR PLASTIC TO PLASTIC STROKES) THE DEVICE WITH A GREEN LOAD ACROSS A VERY THICK RECTUM THAT THE SURGEON WAS UNABLE TO OPEN THE JAW. THE SURGEON USED THE RED REVERSING SWITCH AND BLACK HANDLE BUT STILL WAS UNABLE TO REMOVE. THE SURGEON THEN WAS ABLE TO PLACE A CONTOUR (GREEN) DISTAL TO THE DEVICE AND SUCCESSFULLY COMPLETED THE TRANSACTION AND REMOVED THE SPECIMEN. IT IS NOT CLEAR AS TO HOW THE SURGEON REMOVED THE DEVICE FROM THE SPECIMEN, BUT THE SURGEON DID. THE DEVICE WAS DISCARDED DUE TO THE FACT THAT THE PATIENT HAD A HIGHLY CONTAGIOUS INFECTION. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1