BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH

    MDR report key: 1584392 · Received December 22, 2009

    Report

    Report Number
    1584392
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Date of Event
    December 4, 2009
    Report Date
    December 22, 2009
    Manufacturer
    ETHICON ENDO-SURGICAL, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE FOLLOWING PORTION OF THE OPERATION TO LAPAROSCOPIC ALLY REMOVE THE PATIENT'S KIDNEY, A BRAND NEW STAPLER FAILED TO FIRE (AT THE TIME TO TAKE THE RENAL HILUM): "THE TAIL OFGEROTA'S WAS DISSECTED UP OFF THE PSOAS MUSCLE AND THE URETER WAS DISSECTED UP WITH THE TAIL OF GEROTA'S AND WAS TRANSECTED WITH A STAPLE FIRE. DISSECTION WAS THEN CARRIED CEPHALAD ALONG THE MEDIAL ASPECT OF THE KIDNEY AND THE RENAL HILUM WAS ISOLATED AND THEN TRANSECTED WITH THE STAPLE FIRE. A STAPLE FIRE WAS USED TO TRANSECT THE TISSUES ALONG THE ANTERIOR MEDIAL ASPECT OF THE KIDNEY." ANOTHER STAPLER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM. THE MANUFACTURER'S REPRESENTATIVE WAS PRESENT AND TOOK THE STAPLER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGICAL, INC. ATS45 F4PNOT

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR