BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 1972859 · Received January 28, 2011

    Report

    Report Number
    1527736-2011-00027
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 4, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PREMATURE SLED MOVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CARDIAC PROCEDURE (THE SPECIFIC PROCEDURE IS UNKNOWN), THE DEVICE WAS LOCKED CLOSED AND WOULD NOT FIRE. IT IS UNKNOWN IF THE DEVICE WAS STUCK ON TISSUE. IT IS UNKNOWN IF THERE WAS ANY TISSUE DAMAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK G4UC1J

    Patients

    Seq Age Sex Outcome Treatment
    1