BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2002515 · Received February 28, 2011

    Report

    Report Number
    1527736-2011-00051
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 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
    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 LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE WAS FIRED ACROSS THE APPENDIX. PER THE SURGEON, THE DEVICE HAD NOT COMPLETED THE FIRING SEQUENCE. THE APPENDIX WAS TRANSECTED AND FELL AWAY FROM THE JAWS. AFTER FIRING, THE SURGEON ATTEMPTED TO REMOVE THE DEVICE FROM THE PATIENT AND WAS UNABLE. THE DEVICE WOULD NOT DISARTICULATE AND WOULD NOT OPEN. THE DEVICE HAD TO BE PULLED OUT OF THE PATIENT WITH THE TROCAR. A NEW TROCAR WAS INSERTED. THE TRANSECTION OF THE APPENDIX WAS COMPLETE AT THIS POINT; THEREFORE, THERE WAS NO NEED TO OPEN A NEW DEVICE. THE DEVICE WILL NOT BE RELEASED BY THE ACCOUNT. THE SURGEON STATED THE DEVICE DID NOT FEEL RIGHT WHEN FIRED, DID DEPRESS THE KNIFE BLADE SWITCH BUT FORGOT TO PULL THE HANDLE TO REVERSE THE BLADE. THE SURGEON HAS BEEN INSERVICED BUT IS NOT A FREQUENT USER OF THE DEVICE. SALES REP PROVIDED ADDITIONAL INSERVICE AS RESULT OF THE EVENT.

    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 ECR60B