BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1822191 · Received December 3, 2007

    Report

    Report Number
    1527736-2007-08178
    Event Type
    Malfunction
    Date Received
    December 3, 2007
    Date of Event
    November 6, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THORACOTOMY PROCEDURE THE STAPLER WHEN FIRED HAD AN INCOMPLETE STAPLE LINE, THEY SUTURED OVER THE STAPLE LINE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4HN1D

    Patients

    Seq Age Sex Outcome Treatment
    1