BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1082937 · Received July 25, 2008

    Report

    Report Number
    3005075853-2008-00696
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 8, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/25/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE FIRING LEVER MOVED BACK TO THE ORIGINAL POSITION AND WOULD NOT CUT AT THE SECOND STROKE OF THE SECOND FIRING. THE DOCTOR TRIED TO RELEASE, BUT THERE WAS NO FEEDBACK FROM THE RELEASE BUTTON. THE DEVICE WAS LOCKED ON TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER GDW ETHICON ENDO-SURGERY, LLC. NA D4JY88

    Patients

    Seq Age Sex Outcome Treatment
    1 NP